| CTRI Number |
CTRI/2025/11/097914 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This cross-sectional study aims to assess the risk of obstructive sleep apnea and quality of sleep among patients with endocrine disorders attending selected tertiary care hospital, Mangaluru, Karnataka. A total of 285 participants aged 35-70 years diagnosed with diabetes mellitus, hypothyroidism and obesity will be included. Data will be collected using a demographic proforma, clinical proforma, STOP-Bang Questionnaire for obstructive sleep apnea and Pittsburgh Sleep Quality Index (PSQI) for evaluating quality of sleep. The study will also examine the correlation between obstructive sleep apnea and quality of sleep, as well as the association of both variables with selected demographic variables. Findings will help to identify the high- risk groups and contributing to improving screening and management strategies for sleep problems in endocrine disorders. |