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

Phase 3

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: APAP - Therapy

• Registration Number: NCT01303198
• Lead Sponsor: Kaiserswerther Diakonie

Brief 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).

Study Timeline

• Study Start: 2001-06
• Status Verified: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-23
• Last Update Submitted: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP	APAP - Therapy	Use of CPAP as treatment for sleep apnea
APAP	APAP - Therapy	Use of APAP as treatment for sleep apnea

Primary Outcome Measures

Name	Time	Method
AHI- score (apnea- hypopnea- index)	3 months	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).

Secondary Outcome Measures

Name	Time	Method
Number of device-using hours	3 months	Number of device-using hours as a means to assess patient compliance with the treatment

Trial Locations

Locations (1)

Florence-Nightingale-Krankenhaus; 🇩🇪 Düsseldorf, Nordrhein Westphalen, Germany