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Completed

NCT Number: NCT04759456

Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

The purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brno

Brno, 625 00, Czechia

About this study

The intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy.

The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent
  • newly diagnosed obstructive sleep apnea
  • Apnea-Hypopnea Index greater than 15 episodes/hour
  • indicated for CPAP therapy

Exclusion criteria

  • severe pulmonary hypertension
  • severe heart valve disease
  • COPD III or IV
  • central sleep apnea
  • chronic corticosteroid therapy
  • long-term oxygen therapy
  • heart failure
  • left ventricular ejection fraction lower than 40 %
  • NYHA III or IV
  • cerebrovascular disease
  • psychiatric disease
  • another type of obstructive sleep apnea treatment
  • acute coronary syndrome in anamnesis

Treatment and study plan

Remotely-supervised rehabilitation program

Other

Include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy

Primary outcomes

  1. Change from Baseline in Apnea-Hypopnea Index at Week 12

    Time frame: Baseline and Week 12

    Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome.

  2. Change from Baseline in Epworth Sleepiness Scale Score at Week 12

    Time frame: Baseline and Week 12

    ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome.

  3. Change from Baseline in SF-36 Questionnaire Score at Week 12

    Time frame: Baseline and Week 12

    SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome.

  4. Changes from Baseline in Body composition at Week 12

    Time frame: Baseline and Week 12

    Measure will be taken from InBody 370.

  5. Change from Baseline in 6 Minutes Walking Test at Week 12

    Time frame: Baseline and Week 12

    6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome.

  6. Change from Baseline in Maximal Inspiratory Pressure at Week 12

    Time frame: Baseline and Week 12

    Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.

  7. Change from Baseline in Maximal Expiratory Pressure at Week 12

    Time frame: Baseline and Week 12

    Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome.

Secondary outcomes

  1. Change from Baseline in Oxygen Desaturation Index at Week 12

    Time frame: Baseline and Week 12

    Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.

  2. Change from Baseline in Neck/Waist/Hip circumferences at Week 12

    Time frame: Baseline and Week 12

    All circumferences will be measured by tape measure.

  3. Change from Baseline in Body Mass Index at Week 12

    Time frame: Baseline and Week 12

    BMI will be calculated of participant's current weight and height.

  4. Change from Baseline in Forced Vital Capacity at Week 12

    Time frame: Baseline and Week 12

    Measure will be taken from Spirometry.

  5. Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12

    Time frame: Baseline and Week 12

    Measure will be taken from Spirometry.

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2021
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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