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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01303198
• Other study ID #: Kaiserswertherdiakonie
• Status: Recruiting
• Phase: Phase 3
• First received: February 22, 2011
• Last updated: February 23, 2011
• Start date: June 2001
• Est. completion date: April 2011

Study information

• Verified date: February 2011
• Source: Kaiserswerther Diakonie
• Contact: Hartmut Grüger
• Phone: 0211 4093519
• Email: grueger[@]kaiserswerther-diakonie.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes

Intervention

Device:
• APAP - Therapy
automatic positive pressure therapy

Locations

Country	Name	City	State
Germany	Florence-Nightingale-Krankenhaus	Düsseldorf	Nordrhein Westphalen

Sponsors (2)

Lead Sponsor	Collaborator
Kaiserswerther Diakonie	ResMed Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of device-using hours	Number of device-using hours as a means to assess patient compliance with the treatment	3 months	No