| CTRI Number |
CTRI/2026/02/105018 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Can a 12-Week Supervised Program Improve Life with Sleep Apnea? A Study of Short- and Long-Term Benefits |
|
Scientific Title of Study
|
Short-term effect of 12-week Comprehensive Supervised Intervention Program (SIP) on functioning of Individuals with Obstructive Sleep Apnea based on ICF
Domains: 1-Year Follow-Up Experimental 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 |
Santosh P Dobhal |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Health Sciences-MGM School of Physiotherapy School of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, MGM Institute of Physiotherapy 3rd Floor, C-Building, MGM Campus N-6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
ptsantosh07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh P Dobhal |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Health Sciences-MGM School of Physiotherapy School of Physiotherapy |
| Address |
3rd Floor, C-Building, MGM Campus N-6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
ptsantosh07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santosh P Dobhal |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Health Sciences-MGM School of Physiotherapy School of Physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, MGM Institute of Physiotherapy 3rd Floor, C-Building, MGM Campus N-6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
ptsantosh07@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital, N-6 CIDCO Chhatrapati Sambhaji Nagar, Maharshtra, India |
|
|
Primary Sponsor
|
| Name |
MGM Medical college and hospital |
| Address |
N-6 CIDCO Chhatrpati Sambhjinagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MGM Medical college and Hospital |
N6 CIDCO MGM CAMPUS CHHATRPATI SAMBHAJINAGAR |
| MGM School of Physiotherapy |
1ST FLOOR C BUILDING MGM Medical college campus N-6 CIDCO CHHATRPATI SAMBHAJINAGR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Dobhal |
MGM Medical college and Hospital |
Department of Cardiovascular & Respiratory Physiotherapy, MGM Institute of Physiotherapy N-6 CIDCO Chhatrapati Sambhajinagar 431003
Aurangabad
MAHARASHTRA |
9923401079
ptsantosh07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Supervised Intervention Program |
Participants in the intervention group will undergo a 12-week Comprehensive Supervised Intervention Program (SIP) conducted under physiotherapy supervision three times per week. The program integrates progressive aerobic exercise, resistance training, breathing exercises, oropharyngeal exercises, and sleep hygiene education.
During weeks 1–4, participants will perform moderate-intensity aerobic training (brisk walking or cycling) at approximately 60% of maximum heart rate for 20–30 minutes, five days per week. Resistance exercises will include bodyweight squats, modified push-ups, resistance band rows, dumbbell deadlifts, and step-ups (2 sets of 10–12 repetitions, three days per week). Daily breathing practice will include diaphragmatic breathing, alternate nostril breathing, and nasal inhalation–exhalation techniques. Oropharyngeal exercises such as tongue press and soft palate lifts will also be performed.
During weeks 5–8, aerobic intensity will increase to 65–70% of maximum heart rate for 30–40 minutes, five days per week. Resistance training will progress to lunges, planks, chest presses, rows, and shoulder presses (3 sets of 8–10 repetitions, four days per week). Advanced breathing and oropharyngeal strengthening exercises will be incorporated.
During weeks 9–12, interval aerobic training at approximately 70% of maximum heart rate (2-minute high intensity with 3-minute moderate recovery) will be performed for 40 minutes, five days per week. Resistance training will include weighted squats, deadlifts, bench presses, and cable rows (3 sets of 6–8 repetitions). Weekly sleep hygiene education will be provided throughout the program. |
| Comparator Agent |
Control Group |
Participants allocated to the control group will receive standard care consisting of routine clinical management and general lifestyle advice for obstructive sleep apnea as prescribed by the treating physician. This includes general sleep hygiene recommendations (such as maintaining regular sleep–wake timings, avoiding late meals and stimulants before bedtime, and appropriate sleep environment optimization) but will not include the structured supervised exercise, breathing, or oropharyngeal training that is provided to the intervention group. Participants in the control group will continue any prescribed medical treatments (including CPAP therapy if already initiated) and usual follow-up care. They will be contacted periodically to monitor adherence and record outcome measures at baseline, 12 weeks, and 12 months, similar to the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30–60 years. Diagnosed with moderate-to-severe obstructive sleep apnea with an AHI more than or equal to 15 events per hour. Not currently involved in any structured exercise program.
Able to provide informed consent |
|
| ExclusionCriteria |
| Details |
Presence of significant comorbidities such as advanced cardiovascular disease or uncontrolled
hypertension. Previous surgical intervention for OSA. Use of supplemental oxygen or other respiratory aids beyond CPAP. Cognitive impairment MoCA score less than 24 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measures:
1. Sleep Apnea Quality of Life Index (SAQLI).
2. Montreal Cognitive Assessment (MoCA) score.
Secondary Outcome Measures:
1. Changes in Apnea-Hypopnea Index (AHI) and other sleep parameters through
polysomnography.
2. Oxygen saturation
3. Pittsburgh sleep quality index
4. Epworth Sleepiness Scale (ESS) |
Primary Outcome Measures:
1. Sleep Apnea Quality of Life Index (SAQLI).
2. Montreal Cognitive Assessment (MoCA) score.
Secondary Outcome Measures:
1. Changes in Apnea-Hypopnea Index (AHI) and other sleep parameters through
polysomnography.
2. Oxygen saturation
3. Pittsburgh sleep quality index
4. Epworth Sleepiness Scale (ESS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in Apnea-Hypopnea Index (AHI) and other sleep parameters through
polysomnography.
2. Oxygen saturation
3. Pittsburgh sleep quality index
4. Epworth Sleepiness Scale (ESS) |
1. Primary outcome measures will be evaluated at baseline, 12 weeks, 12 month post intervention |
|
|
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)
|
01/06/2027 |
| 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="3"
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 common sleep disorder associated with impaired physical, cognitive, and social functioning. While Continuous Positive Airway Pressure CPAP remains the standard treatment, adherence is often poor. There is a need for comprehensive non-pharmacological interventions that address functional limitations and quality of life.This study aims to evaluate the short-term and long-term effects of a 12-week Comprehensive Supervised Intervention Program SIP on individuals with moderate-to-severe OSA. The intervention includes aerobic training, resistance exercises, breathing techniques, oropharyngeal exercises, and sleep hygiene education. A total of 100 participants aged 30–60 years diagnosed with OSA AHI more than or equal to 15 events per hour will be recruited and randomly allocated into intervention and control groups. Primary outcomes include Sleep Apnea Quality of Life Index SAQLI and Montreal Cognitive Assessment scores. Secondary outcomes include Apnea-Hypopnea Index, oxygen saturation, sleep quality, and daytime sleepiness.Assessments will be conducted at baseline, 12 weeks, and 12 months follow-up. The study is expected to provide evidence for a structured multidisciplinary rehabilitation program in improving functional outcomes in OSA. |