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Clinical Trials/CTRI/2025/07/092044
CTRI/2025/07/092044
Not yet recruiting
Phase 4

A Comparison of Inspiratory Muscle Training with Conventional Breathing Exercise in Patients with Obstructive Sleep Apnea and Hypersomnia.

Dr Prashant Kaushik1 site in 1 country260 target enrollmentStarted: August 25, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Dr Prashant Kaushik
Enrollment
260
Locations
1
Primary Endpoint
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

Overview

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).

ObjectiveTo 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
35.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Recent Neck Surgeries Positive history for recurrent laryngeal spasm Allergy Acute or chronic cardio-respiratory and neuromuscular disease.

Outcomes

Primary Outcomes

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

Time Frame: 24 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dr Prashant Kaushik
Sponsor Class
Other [Self Funding]
Responsible Party
Principal Investigator
Principal Investigator

Prashant Kaushik

Kailash institute of nursing and paramedical sciences

Study Sites (1)

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