Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls. First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown. The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.

Official Title
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Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure

Conditions
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Physical Activity, Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Telecoaching
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AHI > 15 events/hour, measured by polysomnography < 7,500 steps per day Willing to start CPAP treatment Age between 18 and 65 years Signing the written informed consent Exclusion Criteria: Patients with neuromuscular diseases Patients with chronic obstructive pulmonary disease and interstitial lung disease Patients with cardiac failure and ischemic heart failure Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients will receive standard care, being CPAP treatment | Device: CPAP<br>* Patients will receive CPAP according to standard care<br>|
| Experimental: Intervention group<br>Patients will receive CPAP and telecoaching | Other: Telecoaching<br>* Patients in the intervention arm will receive a step counter and a cell phone with an app on which the amount of steps are daily sent to. Initial targets on steps per day will be discussed with the patient after an activity monitoring before the telecoaching procedure. Dependent whether the patient reaches his/her proposed goal each week, new goals are set.<br>Device: CPAP<br>* Patients will receive CPAP according to standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in steps per day after 3 months | Steps per day as measured by a step counter | The change will be measured after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with an increase > 1,000 steps per day |  | After 3 months (end of telecoaching) and after 12 months | 
| The proportion of patients with > 7500 steps/day |  | Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months | 
| Change in functional exercise capacity | 6-minute walking distance | 3 months and 12 months compared with baseline | 
| Change in daytime sleepiness | Epworth Sleepiness Scale | 3 months and 12 months compared with baseline | 
| Change in sleep quality | Pittsburgh Sleep Quality Index | 3 months and 12 months compared with baseline | 
| Change in endothelial function | Endo-PAT 2000 measurement | 3 months and 12 months compared with baseline | 
| Change in body composition | Bodystat 1500 measurement | 3 months and 12 months compared with baseline | 
| Change in quality of life | SF-36 questionnaire | 3 months and 12 months compared with baseline | 
| Change in steps per day after 12 months | Steps per day as measured by a step counter | The change will be measured after 12 months |