Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

Brno University Hospital

Status: Active, not recruiting

Conditions: Obstructive Sleep Apnea

Treatments: Other: Remotely-supervised rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04759456

NIG 2/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy.

Treatment:

Other: Remotely-supervised rehabilitation program

Control group

No Intervention group

Description:

Participants will undergo individually titrated CPAP therapy.