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

Sleep Apnea Syndromes Clinical Trial

Official title:
Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01303198
Study type Interventional
Source Kaiserswerther Diakonie
Contact Hartmut Grüger
Phone 0211 4093519
Email grueger@kaiserswerther-diakonie.de
Status Recruiting
Phase Phase 3
Start date June 2001
Completion date April 2011
View Details
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