NCT01303198

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

Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kaiserswerther Diakonie · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	APAP - Therapy	automatic positive pressure therapy

Timeline

• Start date: 2001-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-02-24
• Last updated: 2011-02-24

Locations

1 site across 1 country: Germany