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CTRI Number  CTRI/2025/02/080946 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of breathing and oral exercises in patients with breathing issues during sleep 
Scientific Title of Study   Effect of comprehensive rehabilitation on apnea hypopnea index in patients with severe obstructive sleep apnea: a pre-post 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  Mrudula Pawar 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  8401236509  
Fax    
Email  pawarmrudula05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prem V 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore Bangalore

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Prem V 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore Bangalore


KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road,Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prem V  Manipal Hospitals Bangalore  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore
Bangalore
KARNATAKA 		 9886647732

prem.v@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive Rehabilitation  Functional Nasal Breathing Rehabilitation techniques Myofunctional Therapy Diaphragmatic Breathing Exercise Frequency - 3 times/day for 5 days a week Duration - For 12 weeks 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with severe OSA
2. BMI less than 40 kg/m2 
 
ExclusionCriteria 
Details  1. Patients with obstructive nasal disease such as allergic rhinitis.
2. Individuals with craniofacial malformations.
3. Patients diagnosed with comorbid sleep disorders such as
insomnia, restless leg syndrome.
4. Pregnant women
5. Patients with history of pharyngeal surgery.
6. Patients with history of congestive heart failure, cardiomyopathy,
chronic obstructive pulmonary disease, liver cirrhosis.
7. Patients with history of neuromuscular disorders such as
myasthenia gravis, motor neuron disease, demyelinating diseases.
8. Patients with history of stroke.
9. Patients with psychiatric illness such as schizophrenia, anxiety
disorder, obsessive compulsive disorder, bipolar disorder, attention
deficit disorder and hyperactivity disorder.
10. Consumption of alcoholic beverages regularly.
11. Periodontal disease (gingivitis)
12. Temporomandibular Joint dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Apnea Hypopnea Index
2. Epworth Sleepiness Scale 		 1. At baseline (0 weeks), End of the treatment
(12 weeks)
2. At baseline (0 weeks), End of the treatment
(12 weeks), Follow up (24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oxygen Desaturation Index  At baseline (0 weeks), End of the treatment
(12 weeks) 
Snoring Index  At baseline (0 weeks), End of the treatment
(12 weeks) 
Pittsburg Sleep Quality Index  At baseline (0 weeks), End of the treatment
(12 weeks), Follow up (24 weeks) 
Manual Assessment of Respiratory Motion  At baseline (0 weeks), End of the treatment
(12 weeks), Follow up (24 weeks) 
Breath Hold Test  At baseline (0 weeks), End of the treatment
(12 weeks), Follow up (24 weeks) 
Self Evaluation of Breathing Questionnaire  At baseline (0 weeks), End of the treatment
(12 weeks), Follow up (24 weeks) 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/02/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 breathing disorder which is sleep-related, marked by episodes of decreased and complete stoppage of ventilation (hypopnea and apnea)”. It is characterized by recurrent obstruction of the upper airway in sleep leading to oxyhaemoglobin desaturation and arousals from deep sleep. In India, the prevalence of OSA was 52 million as of 2021. OSA risk increases with age.
Evidence has shown that CPAP decreases the severity of OSA and improves sleep quality. However, there are side effects of CPAP which results in decreased adherence of patients to the treatment. Comprehensive rehabilitation for OSA focuses on the modification of oral and oronasal breathing, improving oropharyngeal muscles, and correcting paradoxical breathing patterns. It rehabilitates the patient through functional nasal breathing techniques, isotonic and isometric oropharyngeal exercises, and diaphragmatic breathing technique. The primary objectives of the study are to determine the effect of comprehensive rehabilitation on AHI and excessive day time sleepiness among patients with severe OSA. The secondary objectives are to determine its effect on oxygen desaturation, snoring, sleep quality, and on the components of breathing dysfunction.
 
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