Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

  • STATUS
    Recruiting
  • End date
    Oct 7, 2023
  • participants needed
    50
  • sponsor
    Brno University Hospital
Updated on 7 May 2022

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 30-60 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.

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.

Details
Condition Obstructive Sleep Apnea
Treatment Remotely-supervised rehabilitation program
Clinical Study IdentifierNCT04759456
SponsorBrno University Hospital
Last Modified on7 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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