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CTRI Number  CTRI/2025/11/097914 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 26/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of the risk of obstructive sleep apnea and the quality of sleep among patients with endocrine disorders. 
Scientific Title of Study   A study to asses the risk of obstructive sleep apnea and quality of sleep among patients with endocrine disorders. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIl  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ningthoujam Leishana Chanu 
Designation  2nd Year MSc Nursing  
Affiliation  Student 
Address  Room no.5, 4th floor, Department of Medical Surgical Nursing, Yenepoya Nursing College, University road, Naringana, Manjanady, Mangalore,575018
Room no.5, 4th floor, Department of Medical Surgical Nursing, Yenepoya Nursing College, Naringana, Manjanady, Mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  8787785894  
Fax    
Email  leishana2247@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hezil Reema Barboza 
Designation  Associate Professor 
Affiliation  Faculty 
Address  Room no.5, 4th floor, Department of Medical Surgical Nursing, Yenepoya Nursing College, University road, Naringana, Mandanady, Mangalore, 575018
Room no.5, 4th floor, Department of Medical Surgical Nursing, Yenepoya Nursing College, Naringana, Manjanady, Mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9008218663  
Fax    
Email  hezilreemabarboza@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hezil Reema Barboza 
Designation  Associate Professor  
Affiliation  Faculty 
Address  Room no.5, 4th floor,Department of Medical Surgical Nursing, Yenepoya Nursing College, University road, Naringana, Manjanady, Mangalore,575018
Room no.5, 4th floor,Department of Medical Surgical Nursing, Yenepoya Nursing College, Naringana, Manjanady, Mangalore,575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9008218663  
Fax    
Email  hezilreemabarboza@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Medical College Hospital, University road, Deralakatte,Mangalore 
 
Primary Sponsor  
Name  Ningthoujam Leishana Chanu 
Address  Yenepoya Nursing College, University road,Naringana, Manjanady, Mangalore, 575018 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hezil Reema Barboza  Yenepoya Medical College Hospital  Room no.4, Ground floor, Department of endocrinology
Dakshina Kannada
KARNATAKA 
9008218663

hezilreemabarboza@gmail.com 
Ningthoujam Leishana Chanu  Yenepoya Medical College Hospital  Room no. 4, Ground floor, Department of endocrinology
Dakshina Kannada
KARNATAKA 
8787785894

leishana2247@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YENEPOYA ETHICS COMMITTEE-3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified, (2) ICD-10 Condition: E669||Obesity, unspecified, (3) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients diagnoses with Diabetes mellitus, Hypothyroidism and Obesity 
 
ExclusionCriteria 
Details  Patients who are
1.Critically ill
2.Diagnosed and treated-OSA, sleep disorders
3.Known for psychiatric illness or neurological conditions affecting sleep
4.On medications such as sedatives and hypnotics 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of obstructive sleep apnea risk (STOP- Bang Score) and sleep quality (PSQI) Score) among patients with endocrine disorders at a single timepoint.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Correlation between the risk of obstructive sleep apnea (STOP-Bang score) & quality of sleep (PSQI score).
2. Association between OSA risk levels (STOP-Bang categories) & selected demographic variables.
3. Association between sleep quality (PSQI categories) & selected demographic variables. 
At baseline 
 
Target Sample Size   Total Sample Size="285"
Sample Size from India="285" 
Final Enrollment numbers achieved (Total)= "285"
Final Enrollment numbers achieved (India)="285" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2025 
Date of Study Completion (India) 31/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Brief Summary

Obstructive sleep apnea (OSA) is a common but frequently underdiagnosed sleep-related breathing disorder that is associated with significant cardiovascular, metabolic, and neurocognitive complications. Patients with endocrine disorders, particularly Type 2 Diabetes Mellitus (T2DM), hypothyroidism, and obesity, are at an increased risk of developing OSA and poor sleep quality. Early identification of individuals at risk may facilitate timely intervention and improve health outcomes.

This cross-sectional study was conducted to assess the risk of obstructive sleep apnea and quality of sleep among patients with endocrine disorders attending a selected tertiary care hospital in Mangaluru, Karnataka. The study included 285 participants aged 35–70 years diagnosed with Type 2 Diabetes Mellitus, hypothyroidism, and obesity. Participants who were previously diagnosed with OSA or receiving treatment for OSA were excluded.

Data were collected using a demographic proforma, clinical proforma, the STOP-Bang Questionnaire to assess the risk of obstructive sleep apnea, and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. The study also examined the relationship between OSA risk and sleep quality and their association with selected demographic and clinical variables.

The findings demonstrated that patients with Type 2 Diabetes Mellitus and obesity had a higher risk of OSA and poorer sleep quality compared with patients with hypothyroidism. A significant positive correlation was observed between OSA risk and poor sleep quality. Age, comorbidities, and selected demographic factors were significantly associated with OSA risk and sleep quality. The study highlights the importance of routine screening for OSA and sleep disturbances among patients with endocrine disorders to enable early diagnosis, timely referral, and appropriate management, thereby improving overall health outcomes and quality of life.

 
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