Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home

Study Overview
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Brief Summary
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Primary hypothesis: The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions. Secondary hypothesis: Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory: Objective measures: mask leakage pressure Apnea-Hypopnea-Index (AHI) Subjective measures: quality of life sleepiness

Official Title
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Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.

Conditions
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Patient Compliance

Intervention / Treatment
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* Procedure: Automatic Positive Airway Pressure (APAP) initiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent from patients after verbally and written informing Age between 18 and 80 Years obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy Exclusion Criteria: Intolerance to wear the PAP therapy mask sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders disabilities who prevents the wear of a therapy mask initiated PAP therapy pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty) modified Mallampati Score T3 and T4 participation on clinical studies 4 weeks before start of the study known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study. chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease) acute internistic disease neuromuscular disease condition after Apoplexy oncological disease in recent 5 years drug/alcohol consumption consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APAP Lab<br>standard Initiation of APAP therapy in sleep laboratory. | Procedure: Automatic Positive Airway Pressure (APAP) initiation<br> <br> |
| Experimental: APAP Home<br>initiation of APAP therapy in homely environment with additional continuous telemetric support. | Procedure: Automatic Positive Airway Pressure (APAP) initiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of usage hours of of positive airway pressure therapy per night |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index [1 / hour of sleep) |  | 6 month |