Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
NCT ID: NCT04759456
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2021-10-25
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.
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
Control group
Participants will undergo individually titrated CPAP therapy.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed obstructive sleep apnea
* Apnea-Hypopnea Index greater than 15 episodes/hour
* indicated for CPAP therapy
Exclusion Criteria
* 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
25 Years
65 Years
MALE
No
Sponsors
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Brno University Hospital
OTHER
Responsible Party
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Jakub Hnatiak, MSc.
MSc.
Locations
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University Hospital Brno
Brno, , Czechia
Countries
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References
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Hnatiak J, Zikmund Galkova L, Winnige P, Batalik L, Dosbaba F, Ludka O, Krejci J. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 18;12:e47460. doi: 10.2196/47460.
Other Identifiers
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NIG 2/20
Identifier Type: -
Identifier Source: org_study_id
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