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临床试验/CTRI/2025/07/092044
CTRI/2025/07/092044尚未招募4 期

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

Dr Prashant Kaushik1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
260
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 24 weeks

次要结局

  • 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)

研究者

发起方
Dr Prashant Kaushik
申办方类型
Other [Self Funding]
责任方
Principal Investigator
主要研究者

Prashant Kaushik

Kailash institute of nursing and paramedical sciences

研究点 (1)

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