Clinical trial NCT04759456: Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
Official title: Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Remotely-supervised rehabilitation program
Apnea-Hypopnea Index
Telemonitoring
Telecoaching
Telerehabilitation
CPAP
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 50
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Apnea-Hypopnea Index at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Epworth Sleepiness Scale Score at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in SF-36 Questionnaire Score at Week 12
timeFrame: Baseline and Week 12
measure: Changes from Baseline in Body composition at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in 6 Minutes Walking Test at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Maximal Inspiratory Pressure at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Maximal Expiratory Pressure at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in Oxygen Desaturation Index at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Neck/Waist/Hip circumferences at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Mass Index at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Forced Vital Capacity at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
References: