Autoset T Versus CPAP Therapy, a Comparison of Titration and Therapy

Study Overview
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Brief Summary
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Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual and automatical titration. Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and device data. Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.

Detailed Description
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A cross over, simple blind study design has been created for a controlled trial to compare pressure titration and therapy with the Autoset T device. Part 1: After a baseline polysomnography (PSG) a selected group of patients with obstructive sleep apnea will be titrated in two more nights in a sleep lab under APAP mode and CPAP mode. We compare the sleep quality and the AHI, oxygen saturation, leakage. Part 2: Over a time range of 12 weeks the patients got two kinds of therapy modes at home: CPAP and APAP (each six weeks. We compare the objective and subjective therapy by compliance, device data, Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI, german version).

Official Title
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Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Device: APAP - Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 18 to 80 years Exclusion Criteria: pregnancy insomnia consumption of soporifics pulmonal or cardial diseases operation advised by ear, nose and throat specialist missing linguistic skills in german

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP<br>Use of CPAP as treatment for sleep apnea | Device: APAP - Therapy<br>* automatic positive pressure therapy<br>|
| Active Comparator: APAP<br>Use of APAP as treatment for sleep apnea | Device: APAP - Therapy<br>* automatic positive pressure therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI- score (apnea- hypopnea- index) | AHI (apnea- hypopnea- index): Number of Apneas and Hypopneas/hour as a function of the type of positive airway pressure supply used- automated (APAP) vs. the standard, manually titrated and fixes continuous (CPAP). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of device-using hours | Number of device-using hours as a means to assess patient compliance with the treatment | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, APAP, sleep apnea