| CTRI Number |
CTRI/2026/01/101796 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Poor Sleep Affects Muscle Strength and Tiredness in People with Sleep Apnea |
|
Scientific Title of Study
|
Association between sleep quality with peripheral muscle strength and fatigue in Individuals with Obstructive Sleep apnea: A cross-sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bavatharani k |
| Designation |
PG Resident |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
7/6 veerapandi amman kovil street dindigul
Coimbatore
TAMIL NADU
624001
India |
| Phone |
8610092488 |
| Fax |
|
| Email |
bavatharanisbb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Kalpana A P |
| Designation |
Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
Department of Physiotherapy,
Room mo. 001, Sf no. 259 and 267, kalapatti post coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9842090310 |
| Fax |
|
| Email |
apkalpanapt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bavatharani k |
| Designation |
PG Resident |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
7/6 veerapandi amman kovil street dindigul
Coimbatore
TAMIL NADU
624001
India |
| Phone |
8610092488 |
| Fax |
|
| Email |
bavatharanisbb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai medical center and hospital |
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
SF No 259 and 267 kalapatti post coimbatore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santhakumar |
Kovai medical center and hospital |
Department of pulmonology,
99 Avinashi road civil aerodrome coimbatore 641014
Coimbatore
TAMIL NADU |
9659163000
drskumar.chest@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed with obstructive sleep apnea
stable medical condition
able to perform 5times sit to stand test and hand grip strength test |
|
| ExclusionCriteria |
| Details |
patient with severe cardiorespiratory condition and patient currently using cpap for treatment, severe obesity, chronic fatigue syndrome, severe upper airway anatomical abnormality, central and mixed sleep apnea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
peripheral muscle strength-
handheld dynamometer, five times sit to stand test |
Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fatigue - fatigue severity scale |
baseline only |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2026 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Obstructive Sleep Apnea (OSA) is a condition where breathing repeatedly stops during sleep, leading to poor sleep quality and low oxygen levels at night. This can make people feel tired during the day and may affect their muscle strength.
This study aims to find out if poor sleep in OSA patients is linked to weaker muscles and increased fatigue. We will assess sleep quality using a sleep test (polysomnography), focusing on factors like breathing interruptions (AHI), oxygen levels, and sleep efficiency.
Muscle strength will be measured using a hand-held dynamometer and a sit-to-stand test. Fatigue levels will be checked using the Fatigue Severity Scale.
By comparing sleep data with strength and fatigue, we hope to understand how sleep problems affect physical health. The findings can help improve treatment plans to not only manage sleep but also improve energy and strength in people with OSA. |