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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">JSDR</journal-id>
      <journal-title-group>
        <journal-title>Journal of Sleep And Sleep Disorder Research</journal-title>
      </journal-title-group>
      <issn pub-type="epub">2574-4518</issn>
      <publisher>
        <publisher-name>Open Access Pub</publisher-name>
        <publisher-loc>United States</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">JSDR-24-5271</article-id>
      <article-id pub-id-type="doi">10.14302/issn.2574-4518.jsdr-24-5271</article-id>
      <article-categories>
        <subj-group>
          <subject>research-article</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Assessing the risk of Obstructive Sleep Apnea in Type 2 Diabetes Mellitus patients in India</article-title>
        <alt-title alt-title-type="running-head">osa risk in indian t2dm patients</alt-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Rajiv</surname>
            <given-names>Kovila</given-names>
          </name>
          <xref ref-type="aff" rid="idm1842023268">1</xref>
          <xref ref-type="aff" rid="idm1842036204">*</xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Lakshmi</surname>
            <given-names>Vinuthna Reddy</given-names>
          </name>
          <xref ref-type="aff" rid="idm1842023772">2</xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Ansh</surname>
            <given-names>Marfatia</given-names>
          </name>
          <xref ref-type="aff" rid="idm1842024204">3</xref>
        </contrib>
      </contrib-group>
      <aff id="idm1842023268">
        <label>1</label>
        <addr-line>Diploma Diabetology, MBBS, FRCP, Nanavati Hospital: LIC Colony, Suresh Colony, Vile Parle, Mumbai, Maharashtra, 400056 </addr-line>
      </aff>
      <aff id="idm1842023772">
        <label>2</label>
        <addr-line>Samatvam Diabetes Endocrinology and Medical Centre, Samatvam: Science and Research for Human Welfare trust </addr-line>
      </aff>
      <aff id="idm1842024204">
        <label>3</label>
        <addr-line>Montgomery High School , Montgomery High School </addr-line>
      </aff>
      <aff id="idm1842036204">
        <label>*</label>
        <addr-line>Corresponding Author </addr-line>
      </aff>
      <author-notes>
        <corresp>
    
    Rajiv Kovila, <addr-line>Diploma Diabetology, MBBS, FRCP, Nanavati Hospital: LIC Colony, Suresh Colony, Vile Parle, Mumbai, Maharashtra, 400056,</addr-line><email>rajivrkovil1@gmail.com</email></corresp>
        <fn fn-type="conflict" id="idm1842130780">
          <p>The authors declare no conflict of interest.</p>
        </fn>
      </author-notes>
      <pub-date pub-type="epub" iso-8601-date="2024-11-08">
        <day>08</day>
        <month>11</month>
        <year>2024</year>
      </pub-date>
      <volume>2</volume>
      <issue>1</issue>
      <fpage>17</fpage>
      <lpage>27</lpage>
      <history>
        <date date-type="received">
          <day>28</day>
          <month>08</month>
          <year>2024</year>
        </date>
        <date date-type="accepted">
          <day>26</day>
          <month>10</month>
          <year>2024</year>
        </date>
        <date date-type="online">
          <day>08</day>
          <month>11</month>
          <year>2024</year>
        </date>
      </history>
      <permissions>
        <copyright-statement>© </copyright-statement>
        <copyright-year>2024</copyright-year>
        <copyright-holder>Rajiv Kovila, et al</copyright-holder>
        <license xlink:href="http://creativecommons.org/licenses/by/4.0/" xlink:type="simple">
          <license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p>
        </license>
      </permissions>
      <self-uri xlink:href="http://openaccesspub.org/jsdr/article/2172">This article is available from http://openaccesspub.org/jsdr/article/2172</self-uri>
      <abstract>
        <sec id="idm1841882532">
          <title>Background/Aim</title>
          <p>Obstructive Sleep Apnea (OSA) is a prevalent disorder characterized by recurrent respiratory disturbances during sleep. Patients with Type 2 Diabetes Mellitus (T2DM) and obesity exhibit a substantial susceptibility to OSA (23%–86%).                 People with OSA have a high risk of several comorbidities like insulin resistance, cardiovascular disease, depressed mood and hypertension. Thus, the objective was to comprehensively evaluate the risk of OSA among T2DM patients in India.</p>
        </sec>
        <sec id="idm1841881596">
          <title>Materials and Methods</title>
          <p>A cross-sectional survey was conducted across four cities in India involving 2,000 T2DM patients. The survey gathered data on patient demographics, clinical                 endpoints, and estimated the risk of OSA using an app which included the STOP BANG questionnaire. Multivariate logistic regression analysis was used to                   evaluate the association between OSA risk and key variables such as age, gender, BMI, and HbA1c.</p>
        </sec>
        <sec id="idm1841880660">
          <title>Result</title>
          <p>Overall, 63.9% of T2DM patients were identified as high risk and 27.3% were at intermediate risk for OSA development. Results of the multivariate logistic                    regression demonstrated that patients with high BMI ≥35 had significantly greater odds (OR: 5.70; p&lt;0.00) of developing OSA; males had 2.75 times higher odds (p&lt;0.00) and patients with HbA1c value &gt;8% had higher odds (OR: 1.22; p&lt;0.00) of developing OSA. </p>
        </sec>
        <sec id="idm1841881236">
          <title>Conclusion</title>
          <p>OSA risk and prevalence are significantly higher in T2DM patients than in the general population with a notable escalation in patients who are overweight/obese, older, and have prolonged diabetes duration. Early screening using                        digitalization with a highly sensitive, cost-efficient, and valid tool like                          STOP-BANG followed by appropriate intervention for OSA can not only reduce the eventual economic burden but can improve patient outcomes.</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>Obstructive Sleep Apnea</kwd>
        <kwd>Type 2 Diabetes Mellitus</kwd>
        <kwd>STOP-BANG</kwd>
      </kwd-group>
      <counts>
        <fig-count count="3"/>
        <table-count count="3"/>
        <page-count count="11"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <sec id="idm1841880588" sec-type="intro">
      <title>Introduction</title>
      <p>According to the International Diabetes Federation (IDF), diabetes has reached epidemic proportions in many developing economies such as India which has about 77 million individuals who are diagnosed with type 2 diabetes (T2DM).<xref ref-type="bibr" rid="ridm1841195436">1</xref> This trend is expected to grow with population growth and ageing reaching about 134 million people with T2DM by 2045 constituting to be among the top three countries with the highest burden of diabetes.<xref ref-type="bibr" rid="ridm1841200476">2</xref></p>
      <p>Obstructive sleep apnea (OSA) is a common form of disordered breathing characterized by  inconsistent, partial, or total obstruction of the upper airways leading to periodic desaturation of                 hemoglobin oxygen during sleep and persistent agitation during sleep.<xref ref-type="bibr" rid="ridm1841209380">3</xref> The condition results in               variations in intrathoracic pressure and intermittent decreases or stops in airflow, which can lead to hypoxia, hypercapnia, and repeated awakenings from sleep.<xref ref-type="bibr" rid="ridm1841301100">4</xref> Because of inadequate sleep quality, individuals with OSA encounter daytime fatigue, drowsiness, functional limitations, and a general  decline in their quality of life.<xref ref-type="bibr" rid="ridm1841209380">3</xref> Findings from recent literature estimated that OSA impacts almost 1 billion individuals between the ages of 30-69 years worldwide.<xref ref-type="bibr" rid="ridm1841059060">5</xref> In India, the prevalence of OSA is based on several cross-sectional studies across various geographies and varies widely between 23.7% to 95% based on study population, methods, and criteria used for diagnosis.<xref ref-type="bibr" rid="ridm1841054236">6</xref> An increasing amount of research indicates a reciprocal relationship between OSA<xref ref-type="bibr" rid="ridm1841042268">7</xref> and T2DM, both of which are              significant risk precursors for cardiovascular diseases.<xref ref-type="bibr" rid="ridm1841040684">8</xref><xref ref-type="bibr" rid="ridm1841030756">9</xref> Patients with T2DM have a notably high prevalence of OSA (23%–86%).<xref ref-type="bibr" rid="ridm1841026508">10</xref><xref ref-type="bibr" rid="ridm1841014372">11</xref> Results from a recent meta-analysis reported that the                    prevalence of OSA in T2DM patients was 56%. Furthermore, the prevalence of both conditions                    increases with age, male sex, and body mass index (BMI).<xref ref-type="bibr" rid="ridm1841011852">12</xref> Insufficient sleep and disruptions in circadian rhythm have recently been identified as potential contributors to insulin resistance (IR) and the onset of impaired glucose tolerance and T2DM.<xref ref-type="bibr" rid="ridm1841005516">13</xref> Unrecognized or poorly managed OSA in               individuals with T2DM is linked to an increased risk of both microvascular and macrovascular                   complications, such as peripheral arterial diseases, nephropathy, retinopathy, and neuropathy. Despite these risks, OSA often goes undiagnosed and untreated among T2DM patients, mainly due to a lack of awareness among both the general public and healthcare providers.<xref ref-type="bibr" rid="ridm1841005516">13</xref><xref ref-type="bibr" rid="ridm1841020924">14</xref> Guidelines from the IDF and the American Diabetes Association (ADA) recommend routine screening for OSA in all adults diagnosed with T2DM to mitigate the associated diabetes-related complications.<xref ref-type="bibr" rid="ridm1841016388">15</xref> Overnight                   polysomnography is the gold standard test used to diagnose OSA. However, this diagnostic test is                  costly, laborious, and time consuming which limits the use of this test specifically in resource challenged economies and specific populations such as elderly patients.<xref ref-type="bibr" rid="ridm1840980844">16</xref> Owing to the drawbacks of polysomnography, other easy to use and cost-efficient methods have been developed to screen patients for OSA.<xref ref-type="bibr" rid="ridm1840977892">17</xref> Among these, the STOP- BANG questionnaire which measures snoring, tiredness,                  observed apnea, high blood pressure, BMI, age, neck circumference and gender (STOP-BANG) is an easy-to-use, efficient, inexpensive, valid, and reliable alternative screening tool, for OSA.<xref ref-type="bibr" rid="ridm1840973356">18</xref> As there is limited data on the presence of OSA in T2DM patients, the main goal of this cross-sectional study was to estimate the risk and severity of OSA in T2DM patients using a digital mobile friendly app which included the STOP-BANG questionnaire.</p>
    </sec>
    <sec id="idm1841882388" sec-type="materials">
      <title>Materials and Methods</title>
      <sec id="idm1841881164">
        <title>Study design and setting</title>
        <p>The study was designed as a cross-sectional observational study which was conducted across outpatient clinics in four cities Mumbai, Pune, Delhi, and Chennai in India. A total of 20 diabetologists                        participated in the study and each diabetologist was responsible for recruiting a total of 100 T2DM  patients for screening based on the study inclusion criteria. A total of 2,000 patients participated in the study.   Patients were enrolled in the study if they had a diagnosis of T2DM, were &gt; 18 years of age, seeking treatment with the participating doctor for more than three months, could speak and read                English, used an Android phone, and agreed to participate in the study. Patients were excluded if they were diagnosed with any other type of diabetes, such as type 1 diabetes or gestational diabetes, had central sleep apnea, severe uncontrolled psychiatric disorders or psychiatric medication, patients with current or previous substance abuse, and patients undergoing bariatric surgery. The study was approved by independent ethics committees located within each city. Informed consent was obtained from                 participating diabetologists and patients. </p>
      </sec>
      <sec id="idm1841881020">
        <title>Data collection process and tool</title>
        <p>Patients were enrolled in the study over a six-month period (i.e. between January 1, 2023 to June 30, 2023). For this study, to facilitate ease of data collection, we developed an app called EQUIP which patients who agree to participate could download on their mobile phones when they were waiting in the outpatient clinic. The app collected data on patient demographic profiles, comorbid conditions, medical history, and included the STOP-BANG questionnaire as a screening tool for OSA. Patients entered their demographic and clinical data such as hypertension, duration of diabetes, serum creatinine values, cholesterol levels, HbA1c values, fasting plasma glucose, and medical history (previous cardiovascular problems such as myocardial infarction (MI), coronary artery bypass graft (CABG), obesity, and                 kidney disease) from their medical chart records in the EQUIP app.<xref ref-type="bibr" rid="ridm1840971124">19</xref><xref ref-type="bibr" rid="ridm1840982572">20</xref> Anthropometric                      measurements including height, weight, BMI, waist circumference, hip circumference and neck                   circumference were recorded in the clinic and entered in the app. Using responses provided by patients on the STOP-BANG questionnaire the EQUIP app calculated an OSA severity score for each individual patient which assisted in categorizing the patients into one of the three risk groups: low risk (score:               0–2), intermediate risk (score: 3–4), and high risk (score: 5–8). <xref ref-type="bibr" rid="ridm1840952924">21</xref> Participating patients were                   assigned a patient identification number to protect their confidentiality and all data was stored on a password protected server. </p>
      </sec>
      <sec id="idm1841880372">
        <title>Statistical analysis</title>
        <p>Data were analysed using SPSS 20.0. Categorical variables are represented as percentages and                     continuous variables as mean ± standard deviation Risk of OSA was also analysed based on duration of diabetes (&lt;5 years, 5-10 years, 10-15 years, 16-20 years, and &gt; 20 years). Risk factors for OSA were evaluated using logistic regression. A value of <italic>P</italic> &lt; 0.05 was considered statistically significant. </p>
      </sec>
    </sec>
    <sec id="idm1841879292" sec-type="results">
      <title>Results</title>
      <sec id="idm1841879724">
        <title>Demographic and clinical characteristics of patients</title>
        <p>The study included a total of 2,000 patients diagnosed with T2DM. Among these patients’ majority 64.75% were males. Mean age of the patient population was 59.1 (S.D. ±9.36) years, of which 80.80% of the patients were over the age of 50. Out of 2,000 T2DM patients, 46% patients had a BMI index of 35 and above and about 41% patients reported to have a prior incident of MI.  Blood pressure (83.45%), heart problem (57.75%), obesity (61.30%), and kidney disease (41.30%) were the most                reported comorbid conditions.  About half the patient population (49.65%) had HbA1c values &gt;8 mg/dl and majority patients 84.30% had fasting plasma glucose level &gt;125 mg/dl. The demographic and                 clinical characteristics are presented in <xref ref-type="table" rid="idm1840984004">Table 1</xref>.</p>
        <table-wrap id="idm1840984004">
          <label>Table 1.</label>
          <caption>
            <title> Demographic and clinical characteristics of patients with T2DM 20</title>
          </caption>
          <table rules="all" frame="box">
            <tbody>
              <tr>
                <td>
                  <bold>Parameters</bold>
                </td>
                <td>
                  <bold>Total</bold>
                  <bold>(</bold>
                  <bold>n = 2000)</bold>
                </td>
                <td>
                  <bold>%</bold>
                </td>
              </tr>
              <tr>
                <td>
                  <bold>Age (years), mean (SD)</bold>
                </td>
                <td>59.1 (±9.36)</td>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>Gender</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>Male</td>
                <td>1295</td>
                <td>64.75</td>
              </tr>
              <tr>
                <td>Female</td>
                <td>705</td>
                <td>35.25</td>
              </tr>
              <tr>
                <th colspan="3">
                  <bold>Duration of Diabetes</bold>
                </th>
              </tr>
              <tr>
                <td>&lt; 5 years</td>
                <td>449</td>
                <td>22.45</td>
              </tr>
              <tr>
                <td>5-10 years</td>
                <td>912</td>
                <td>45.60</td>
              </tr>
              <tr>
                <td>10-15 years</td>
                <td>334</td>
                <td>16.70</td>
              </tr>
              <tr>
                <td>16-20 years</td>
                <td>187</td>
                <td>9.35</td>
              </tr>
              <tr>
                <td>&gt; 20 years</td>
                <td>118</td>
                <td>5.90</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>BMI (kg/m2)</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>&lt;25</td>
                <td>293</td>
                <td>14.65</td>
              </tr>
              <tr>
                <td>25-34</td>
                <td>967</td>
                <td>48.35</td>
              </tr>
              <tr>
                <td>35-39</td>
                <td>730</td>
                <td>36.50</td>
              </tr>
              <tr>
                <td>&gt;40</td>
                <td>193</td>
                <td>9.65</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>Medical history</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>Blood pressure</td>
                <td>1669</td>
                <td>83.45</td>
              </tr>
              <tr>
                <td>Heart problem (prior MI, CABG, etc)</td>
                <td>1155</td>
                <td>57.75</td>
              </tr>
              <tr>
                <td>Kidney disease (based on creatine values)</td>
                <td>826</td>
                <td>41.30</td>
              </tr>
              <tr>
                <td>Other conditions (unspecified)</td>
                <td>166</td>
                <td>8.30</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>Systolic Blood Pressure (SBP)- (mmHg)</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>&lt;100</td>
                <td>117</td>
                <td>5.85</td>
              </tr>
              <tr>
                <td>100-139</td>
                <td>829</td>
                <td>41.45</td>
              </tr>
              <tr>
                <td>140-159</td>
                <td>857</td>
                <td>42.85</td>
              </tr>
              <tr>
                <td>≥160</td>
                <td>197</td>
                <td>9.85</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>Diastolic Blood Pressure (DBP)-(mmHg)</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>&lt;60</td>
                <td>125</td>
                <td>6.25</td>
              </tr>
              <tr>
                <td>60-80</td>
                <td>838</td>
                <td>41.90</td>
              </tr>
              <tr>
                <td>≥80</td>
                <td>1037</td>
                <td>51.85</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>Fasting Plasma Glucose (FPG)-(mg/DL)</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>&lt;125</td>
                <td>310</td>
                <td>15.50</td>
              </tr>
              <tr>
                <td>125-199</td>
                <td>1148</td>
                <td>57.40</td>
              </tr>
              <tr>
                <td>200-299</td>
                <td>482</td>
                <td>24.10</td>
              </tr>
              <tr>
                <td>≥300</td>
                <td>60</td>
                <td>3.00</td>
              </tr>
              <tr>
                <th colspan="2">
                  <bold>HBA1C (mmol/mol or %)</bold>
                </th>
                <td>
                  <bold> </bold>
                </td>
              </tr>
              <tr>
                <td>&lt;6.4%</td>
                <td>79</td>
                <td>3.95</td>
              </tr>
              <tr>
                <td>6.5%-8%</td>
                <td>885</td>
                <td>44.25</td>
              </tr>
              <tr>
                <td>&gt;8%</td>
                <td>993</td>
                <td>49.65</td>
              </tr>
              <tr>
                <td>Missing Values</td>
                <td>43</td>
                <td>2.15</td>
              </tr>
              <tr>
                <th colspan="3">
                  <bold>High Density Lipoprotein Cholesterol (HDL-C)-(mg/DL)</bold>
                </th>
              </tr>
              <tr>
                <td>&lt;30</td>
                <td>406</td>
                <td>20.30</td>
              </tr>
              <tr>
                <td>30-59</td>
                <td>1344</td>
                <td>67.20</td>
              </tr>
              <tr>
                <td>≥60</td>
                <td>250</td>
                <td>12.50</td>
              </tr>
              <tr>
                <th colspan="3">
                  <bold>Neck circumference</bold>
                </th>
              </tr>
              <tr>
                <td>&lt;40 cm</td>
                <td>1003</td>
                <td>50.15</td>
              </tr>
              <tr>
                <td>&gt;40 cm</td>
                <td>997</td>
                <td>49.85</td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
      </sec>
      <sec id="idm1841768396">
        <title>Risk of OSA assessed with the STOP-BANG questionnaire  </title>
        <p>The patients who scored ≥5 on the STOP-BANG questionnaire were at a high risk of developing OSA, intermediate risk if they scored between 3-4 and had a low risk if they were marked 0-2 on the scale. (<xref ref-type="fig" rid="idm1840805116">Figure 1</xref>) 1278 patients (63.90%), 547 patients (27.35%) and 175 patients (8.75%) were at high,                  intermediate and low risk of developing OSA accordingly, as per the scores. (<xref ref-type="fig" rid="idm1840805260">Figure 2</xref>) The overall median score of the OSA risk for 2,000 T2DM patients were five out of eight indicating that more than half of the patients were at higher risk of OSA. Patients who were male (64.05%), were greater than 50 years of age (80.80%), had received prior treatment for high blood pressure (79.65%), reported feeling tired or fatigued during daytime (75.85%), and had snoring as a symptom (66.00%) were at risk of     developing OSA (<xref ref-type="table" rid="idm1840801588">Table 2</xref>). We also grouped T2DM patients according to time since diagnosis of T2DM and assessed their potential risk of developing OSA.  About 70.30% patients diagnosed with T2DM for a period of 16-20 years were at a higher risk of developing OSA followed by 69.49% (394 patients) diagnosed with T2DM for 10-15 years (<xref ref-type="fig" rid="idm1840786036">Figure 3</xref>). Furthermore, based on findings from                  multiple logistic regression several key factors were associated with an elevated risk of OSA among T2DM patients. As reported in <xref ref-type="table" rid="idm1840815988">Table 3</xref>, males exhibited 2.75 times higher odds of OSA risk compared to females, emphasizing the gender-based susceptibility. Age was also identified as a significant factor, with each one-year increase raising the odds of OSA risk by 1.04. Lastly, BMI emerged as a critical determinant, with T2DM patients having BMI ≥40 facing a substantially elevated risk for developing OSA (OR = 8.65, p = 0.00).  Similarly, patients with HbA1c levels exceeding 8% were also at an                 increased risk of developing OSA.</p>
        <fig id="idm1840805116">
          <label>Figure 1.</label>
          <caption>
            <title> Distribution of STOP-BANG score in T2DM patients</title>
          </caption>
          <graphic xlink:href="images/image1.jpg" mime-subtype="jpg"/>
        </fig>
        <fig id="idm1840805260">
          <label>Figure 2.</label>
          <caption>
            <title> Risk of developing OSA in T2DM patients</title>
          </caption>
          <graphic xlink:href="images/image2.jpg" mime-subtype="jpg"/>
        </fig>
        <table-wrap id="idm1840801588">
          <label>Table 2.</label>
          <caption>
            <title> Risk of OSA based on findings from the STOP-BANG questionnaire 20</title>
          </caption>
          <table rules="all" frame="box">
            <tbody>
              <tr>
                <td>
                  <bold>Variables</bold>
                </td>
                <td> </td>
                <td>
                  <bold>n (%)</bold>
                </td>
              </tr>
              <tr>
                <td>Do you SNORE loudly (louder than talking or loud enough to be heard through closed doors)?</td>
                <td>Yes</td>
                <td>1320 (66.00)</td>
              </tr>
              <tr>
                <td>Do you often feel TIRED, fatigued, or sleepy during the daytime?</td>
                <td>Yes</td>
                <td>1517 (75.85)</td>
              </tr>
              <tr>
                <td>Has anyone OBSERVED you stop breathing during your sleep?</td>
                <td>Yes</td>
                <td>842 (42.10)</td>
              </tr>
              <tr>
                <td>Do you have or are you being treated for high blood PRESSURE?</td>
                <td>Yes</td>
                <td>1593 (79.65)</td>
              </tr>
              <tr>
                <td>BMI more than 35 kg/m<xref ref-type="bibr" rid="ridm1841200476">2</xref>?</td>
                <td>Yes</td>
                <td>963 (48.15)</td>
              </tr>
              <tr>
                <td>AGE over 50 years old?</td>
                <td>Yes</td>
                <td>1620 (81.00)</td>
              </tr>
              <tr>
                <td>NECK circumference &gt;16 inches (40 cm)?</td>
                <td>Yes</td>
                <td>978 (48.90)</td>
              </tr>
              <tr>
                <td>GENDER: Male?</td>
                <td>Yes</td>
                <td>1281 (64.05)</td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
        <fig id="idm1840786036">
          <label>Figure 3.</label>
          <caption>
            <title> Percent patients as per different OSA scores category according to time since diagnosis of T2DM </title>
          </caption>
          <graphic xlink:href="images/image3.jpg" mime-subtype="jpg"/>
        </fig>
        <table-wrap id="idm1840815988">
          <label>Table 3.</label>
          <caption>
            <title> Multivariate logistic regression to assess the association between age, gender, BMI, HbA1c and OSA risk level among T2DM patients</title>
          </caption>
          <table rules="all" frame="box">
            <tbody>
              <tr>
                <td>Covariates</td>
                <td>OR (95% CI)</td>
                <td>p-value</td>
              </tr>
              <tr>
                <td colspan="3">BMI (kg/m<xref ref-type="bibr" rid="ridm1841200476">2</xref>)</td>
              </tr>
              <tr>
                <td>&lt;25</td>
                <td>1</td>
                <td>-</td>
              </tr>
              <tr>
                <td>25-34</td>
                <td>1.93 (1.46-2.55)</td>
                <td>0.00</td>
              </tr>
              <tr>
                <td>35-39</td>
                <td>5.70 (4.15-7.82)</td>
                <td>0.00</td>
              </tr>
              <tr>
                <td>≥40</td>
                <td>8.65 (4.55-16.46)</td>
                <td>0.00</td>
              </tr>
              <tr>
                <td colspan="3">Gender</td>
              </tr>
              <tr>
                <td>Female</td>
                <td>1</td>
                <td>-</td>
              </tr>
              <tr>
                <td>Male</td>
                <td>2.75 (2.23-3.39)</td>
                <td>0.00</td>
              </tr>
              <tr>
                <td>HbA1c (%)</td>
                <td>1.22 (1.12-1.33)</td>
                <td>0.00</td>
              </tr>
              <tr>
                <td>Age (years)</td>
                <td>1.04 (1.03-1.05)</td>
                <td>0.00</td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
      </sec>
    </sec>
    <sec id="idm1841718436" sec-type="discussion">
      <title>Discussion</title>
      <p>The results from this study, utilizing an app-based STOP-BANG questionnaire, indicate a high OSA risk among T2DM patients, significantly influenced by elevated BMI, HbA1c, and systolic blood                pressure. The frequent occurrence of comorbid conditions such as obesity, hypertension, and dyslipidemia emphasize the metabolic interplay between T2DM and OSA. Furthermore, the trend of increasing OSA risk with prolonged diabetes duration highlights the importance of sustained preventive care in T2DM management. Advanced age, particularly in patients over 50, was strongly associated with OSA risk, likely due to physiological aging effects that heighten susceptibility to sleep                     disturbances. These insights underscore the need for age-specific, long term screening and management strategies to enhance outcome for T2DM patients at high risk of OSA.</p>
      <p>The findings of our study can be compared with results from other published literature. A research   undertaken by Algeffari et al. in 201 T2DM patients employing the Berlin questionnaire to assess the OSA risk found that 44.3% patients were identified as having high likelihood of developing OSA.<xref ref-type="bibr" rid="ridm1840948892">22</xref> The study also documented that higher BMI (OR=3.9; 95% CI=1.4, 7.8, p= &lt;0.001) and longer                  duration since diagnosis of diabetes (OR=3.1; 95% CI =1.3, 7.8, p= 0.837) were associated with an increased OSA risk. These results align with our findings suggesting that longer duration of diabetes and a high BMI may have a significant influence on elevating the risk of OSA in T2DM patients.                Another study conducted in Iran, included a sample of 4,021 participants, with 239 diabetic patients utilized the STOP-BANG questionnaire.<xref ref-type="bibr" rid="ridm1840944644">23</xref> This study revealed that 78.6% of the diabetic patients were classified as high risk for developing OSA, in contrast to 35.1% of participants without diabetes. Another cross-sectional study conducted by Shnaimer et al. at the Armed Forces Hospital in Jazan  involving 306 T2DM patients-revealed that the median score of the OSA risk level assessed by the STOP- BANG items was 3 on a scale of 0 to 8, of which 63.1% of the participants  were classified as being at high risk of developing OSA.<xref ref-type="bibr" rid="ridm1840956740">24</xref> Furthermore, a meta-analysis and systematic review                    conducted by Fallahi et al. assessed the OSA prevalence among 2,360 Iranian patients with diabetes.<xref ref-type="bibr" rid="ridm1840934252">25</xref> Their analysis revealed an overall OSA prevalence of 54.5% in T2DM patients with a higher        prevalence observed among females (66.22%) compared to males (63.26%). These findings are like the findings from our study. Comparisons with other published literature underscores the consistency of our findings regarding the effect of high BMI and longer diabetes duration on increasing the OSA risk in T2DM patients. </p>
      <p>Finally, it is important to note that several studies have validated the use of the STOP-BANG score as a tool for OSA screening. For example, in a study by Chung <italic>et al</italic>with 310 obese Canadian patients found that a STOP-Bang score of 4 had high sensitivity (87.5%) and had high negative predictive value (90.5%) for identifying severe OSA.<xref ref-type="bibr" rid="ridm1840931444">26</xref> In another study conducted in the Korean population, Kim <italic>et al.</italic> reported that the STOP-Bang questionnaire had high sensitivity (97% for AHI ≥ 5/h and 98% for AHI ≥ 15/h) for OSA screening in those with suspected OSA.<xref ref-type="bibr" rid="ridm1840928924">27</xref> These findings combined with our current results strongly support the notion that the STOP-Bang questionnaire is a useful tool for OSA screening in different populations. We would also like to emphasize that using the EQUIP app enabled us to reach a larger pool of patients, eased data collection process in outpatient clinics, and improved accuracy of data by reducing missing data as well as data entry errors. </p>
      <p>Future efforts should focus on raising awareness among clinicians and patients about the importance of diagnosing OSA and its connection to T2DM and related complications. OSA is a significant risk              factor for cardiovascular and renal disease specifically in patients with T2DM, yet many cases remain undiagnosed due to lack of symptoms. With rising age and obesity, routine screening is essential to reduce the health and economic burden of OSA. Integrating user-friendly digital OSA screening tools into routine clinical practice can enhance early detection and improve patient outcomes for T2DM  patients. Future studies should focus on treatment and long-term follow-up in these patients to evaluate the benefits of diagnosing OSA.</p>
    </sec>
    <sec id="idm1841716492">
      <title>Limitations</title>
      <p>The study's limitations encompass the absence of polysomnography, considered the gold standard                confirmatory test for diagnosing OSA. Nevertheless, the STOP-BANG questionnaire's high sensitivity and specificity render it a commendable screening tool for OSA. Furthermore, due to the study's                  cross-sectional design, the evaluation of OSA risk's impact on diabetes control and outcomes was not explored. Also, the study did not have a control arm (i.e. participants with no T2DM) to assess the risk of OSA and was conducted in India thereby limiting the generalizability of its results to the geography. Lastly, the study did not assess hypothyroidism, a secondary cause of OSA, within the recruited                     sample.</p>
    </sec>
    <sec id="idm1841717212" sec-type="conclusions">
      <title>Conclusion</title>
      <p>This pan-India survey highlights the significant association between T2DM and OSA risk,                            underscoring the urgent need for early screening and intervention. Identifying at-risk individuals                facilitates timely management of OSA and related comorbidities such as obesity, hypertension, and other cardiovascular disease, ultimately enhancing patient outcomes. A multidisciplinary approach that integrates sleep health assessments into diabetes care is essential for addressing the complex interplay between these conditions. Such an approach can improve the quality of life for individuals with T2DM by mitigating the adverse effects of OSA and associated health issues. In conclusion, the STOP-Bang questionnaire has demonstrated high sensitivity for OSA screening and severity assessment among diabetic patients, thereby supporting its use as a potentially important screening tool for early                      identification of OSA.</p>
    </sec>
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