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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Kaiserswerther Diakonie.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ResMed Foundation
Information provided by:
Kaiserswerther Diakonie
ClinicalTrials.gov Identifier:
NCT01303198
First received: February 22, 2011
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Sleep Apnea Syndromes
Device: APAP - Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

Resource links provided by NLM:


Further study details as provided by Kaiserswerther Diakonie:

Primary Outcome Measures:
  • AHI- score (apnea- hypopnea- index) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Number of device-using hours [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of device-using hours as a means to assess patient compliance with the treatment


Estimated Enrollment: 60
Study Start Date: June 2001
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303198

Contacts
Contact: Hartmut Grüger 0211 4093519 grueger@kaiserswerther-diakonie.de

Locations
Germany
Florence-Nightingale-Krankenhaus Recruiting
Düsseldorf, Nordrhein Westphalen, Germany, 40489
Contact: Hartmut Grüger    0211 4093519      
Sponsors and Collaborators
Kaiserswerther Diakonie
ResMed Foundation
Investigators
Principal Investigator: Hartmut Grueger, Arzt Diakonie Kaiserswerth
  More Information

No publications provided

Responsible Party: Hartmut Grueger, Kaiserswerther Diakonie
ClinicalTrials.gov Identifier: NCT01303198     History of Changes
Other Study ID Numbers: Kaiserswertherdiakonie
Study First Received: February 22, 2011
Last Updated: February 23, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kaiserswerther Diakonie:
CPAP
APAP
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014