| 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
|
|
|
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
|
|
|
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. |