Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Obstructive Sleep Apnea and Comprehensive Remotely-supervised Rehabilitation Program

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Remotely-supervised rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy. | Other: Remotely-supervised rehabilitation program<br>* 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<br>|
| No Intervention: Control group<br>Participants will undergo individually titrated CPAP therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Apnea-Hypopnea Index at Week 12 | Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome. | Baseline and Week 12 | 
| Change from Baseline in Epworth Sleepiness Scale Score at Week 12 | ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome. | Baseline and Week 12 | 
| Change from Baseline in SF-36 Questionnaire Score at Week 12 | SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome. | Baseline and Week 12 | 
| Changes from Baseline in Body composition at Week 12 | Measure will be taken from InBody 370. | Baseline and Week 12 | 
| Change from Baseline in 6 Minutes Walking Test at Week 12 | 6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome. | Baseline and Week 12 | 
| Change from Baseline in Maximal Inspiratory Pressure at Week 12 | Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome. | Baseline and Week 12 | 
| Change from Baseline in Maximal Expiratory Pressure at Week 12 | Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Oxygen Desaturation Index at Week 12 | Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. | Baseline and Week 12 | 
| Change from Baseline in Neck/Waist/Hip circumferences at Week 12 | All circumferences will be measured by tape measure. | Baseline and Week 12 | 
| Change from Baseline in Body Mass Index at Week 12 | BMI will be calculated of participant's current weight and height. | Baseline and Week 12 | 
| Change from Baseline in Forced Vital Capacity at Week 12 | Measure will be taken from Spirometry. | Baseline and Week 12 | 
| Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12 | Measure will be taken from Spirometry. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remotely-supervised rehabilitation program, Apnea-Hypopnea Index, Telemonitoring, Telecoaching, Telerehabilitation, CPAP