COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303198
Recruitment Status : Unknown
Verified February 2011 by Kaiserswerther Diakonie.
Recruitment status was:  Recruiting
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
ResMed Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: APAP - Therapy Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich
Study Start Date : June 2001
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: CPAP
Use of CPAP as treatment for sleep apnea
Device: APAP - Therapy
automatic positive pressure therapy

Active Comparator: APAP
Use of APAP as treatment for sleep apnea
Device: APAP - Therapy
automatic positive pressure therapy

Primary Outcome Measures :
  1. AHI- score (apnea- hypopnea- index) [ Time Frame: 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 :
  1. Number of device-using hours [ Time Frame: 3 months ]
    Number of device-using hours as a means to assess patient compliance with the treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303198

Layout table for location contacts
Contact: Hartmut Grüger 0211 4093519

Layout table for location information
Florence-Nightingale-Krankenhaus Recruiting
Düsseldorf, Nordrhein Westphalen, Germany, 40489
Contact: Hartmut Grüger    0211 4093519      
Sponsors and Collaborators
Kaiserswerther Diakonie
ResMed Foundation
Layout table for investigator information
Principal Investigator: Hartmut Grueger, Arzt Diakonie Kaiserswerth
Layout table for additonal information
Responsible Party: Hartmut Grueger, Kaiserswerther Diakonie Identifier: NCT01303198    
Other Study ID Numbers: Kaiserswertherdiakonie
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011
Keywords provided by Kaiserswerther Diakonie:
sleep apnea
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases