Trials / Active Not Recruiting
Active Not RecruitingNCT04759456
Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Brno University Hospital · Academic / Other
- Sex
- Male
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Remotely-supervised rehabilitation program | 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 |
Timeline
- Start date
- 2021-10-25
- Primary completion
- 2025-12-01
- Completion
- 2026-07-01
- First posted
- 2021-02-18
- Last updated
- 2025-03-07
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT04759456. Inclusion in this directory is not an endorsement.