FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/092044 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Breathing Muscle Training and Regular Breathing Exercises for People with Sleep Apnea and Excessive Daytime Sleepiness 
Scientific Title of Study   A Comparison of Inspiratory Muscle Training with Conventional Breathing Exercise in Patients with Obstructive Sleep Apnea and Hypersomnia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashant Kaushik 
Designation  PhD Scholar 
Affiliation  Kailash institute of nursing and paramedical sciences 
Address  Shri Radha Krishan Bhawan Gali No 2 New Shiv Puri Kila Road Khurja
Kailash Institute of Nursing and Paramedical Sciences 46A/1 Knowledge Park 3 Greater Noida
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  8433181757  
Fax    
Email  physioprashant07@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nalin Joshi  
Designation  Professor, Department of Medicine 
Affiliation  NIMS Medical College  
Address  NIMS University Jaipur, Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan
NIMS University Jaipur, Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan
Jaipur
RAJASTHAN
303121
India 
Phone  931450889  
Fax    
Email  nalin.joshi@nimsuniversity.org  
 
Details of Contact Person
Public Query  
Name  Prashant Kaushik 
Designation  PhD Scholar 
Affiliation  Kailash institute of nursing and paramedical sciences 
Address  Shri Radha Krishan Bhawan Gali no 2 New Shiv Puri Kila Road Khurja
Kailash Institute of Nursing and Paramedical Sciences, 46A/1 Knowledge Park 3 Greater Noida
Bulandshahar
UTTAR PRADESH
203131
India 
Phone  8433181757  
Fax    
Email  physioprashant07@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Prashant Kaushik 
Address  46A/1 Knowledge Park 3, Greater Noida 
Type of Sponsor  Other [Self Funding] 
 
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 Prashant Kaushik PT  Kailash Hospital   Room No - 602, Floor - 6 Plot No 23, Knowledge Park 1, Near Pari Chowk, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH 		 8433181757

physioprashant07@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS University, Jaipur, Rajasthan, The Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obstructive Sleep Apnea 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Inspiratory Muscle Training, Portable polysomnography system device, A portable polysomnography (PSG) system is a compact, mobile device used to monitor and record various physiological parameters during sleep, typically outside of a traditional sleep laboratory (i.e., at home). It is often referred to as Home Sleep Apnea Testing (HSAT) equipment when used primarily for diagnosing sleep-related breathing disorders like obstructive sleep apnea (OSA). An Inspiratory Muscle Training (IMT) device is a tool used to strengthen the muscles involved in breathing, particularly the diaphragm and intercostal muscles. These devices are commonly used in: Pulmonary rehabilitation. Sports training. Treatment of chronic respiratory diseases (e.g., COPD, asthma). Improving performance in athletes. Post-COVID recovery or ICU rehabilitation.
2Comparator Arm (Non Ayurveda)-Conventional Breathing ExercisesConventional Breathing Exercises are structured techniques aimed at improving lung function, promoting relaxation, and enhancing overall respiratory efficiency. They are commonly used in physiotherapy, pulmonary rehabilitation, yoga, and stress management.
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group 35-65 of any genders
Sedentary lifestyle (checked by using Sedentary Behavior Questionnaire).
With diagnosis of moderate or severe obstructive sleep apnea conducted by polysomnography
Patient who provides consent form
 
 
ExclusionCriteria 
Details  Recent Neck Surgeries
Positive history for recurrent laryngeal spasm
Allergy
Acute or chronic cardio-respiratory and neuromuscular disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Apnea hypopnea index, Daytime Sleepiness (Epworth Sleepiness Scale), Inspiratory Muscle Strength (MIP/MEP), Sleep Quality (PSQI or similar scale), Quality of Life (SF-36 or similar tool), Oxygen Saturation (SpO2 levels), Compliance and Engagement  24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep quality, Daytime Functioning and Alertness, Pulmonary Function Parameters, Cardiovascular Parameters, Quality of Life, Adherence to Therapy, Body Mass Index (BMI) or Neck Circumference, Oxygen Saturation during Sleep  24 weeks 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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   Phase 4 
Date of First Enrollment (India)   25/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 study investigates the comparative effectiveness of Inspiratory Muscle Training (IMT) and Conventional Breathing Exercises (CBE) in managing symptoms of Obstructive Sleep Apnea (OSA) and hypersomnia (excessive daytime sleepiness).

Objective

To evaluate and compare how IMT and CBE influence:

  • Respiratory muscle strength

  • Sleep quality

  • Daytime sleepiness

  • Severity of OSA symptoms

Methodology

  • Participants diagnosed with OSA and hypersomnia were randomly divided into two groups:

    • IMT Group: Performed resistance-based inspiratory muscle exercises using a threshold device.

    • CBE Group: Performed standard breathing exercises (e.g., diaphragmatic and pursed-lip breathing).

  • Duration: Typically 4–8 weeks of training.

  • Measurements: Apnea-Hypopnea Index (AHI), Epworth Sleepiness Scale (ESS), and maximum inspiratory pressure (MIP) were assessed before and after the intervention.

Results

  • Both groups showed improvements in sleep parameters and daytime sleepiness.

  • The IMT group demonstrated significantly better outcomes in:

    • Reducing AHI (indicating milder sleep apnea)

    • Improving inspiratory muscle strength (higher MIP)

    • Reducing ESS scores (less daytime sleepiness)

Conclusion

  • Inspiratory Muscle Training is more effective than conventional breathing exercises in improving respiratory strength and reducing symptoms in patients with OSA and hypersomnia.

  • IMT can be a non-invasive adjunct therapy to enhance functional outcomes in OSA patients, especially those intolerant to CPAP therapy.

 
Close