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

February 23, 2011 updated by: Kaiserswerther Diakonie

Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein Westphalen
      • Düsseldorf, Nordrhein Westphalen, Germany, 40489
        • Recruiting
        • Florence-Nightingale-Krankenhaus
        • Contact:
          • Hartmut Grüger
          • Phone Number: 0211 4093519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of device-using hours
Time Frame: 3 months
Number of device-using hours as a means to assess patient compliance with the treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiserswerther Diakonie

Collaborators

ResMed Foundation

Investigators

  • Principal Investigator: Hartmut Grueger, Arzt, Diakonie Kaiserswerth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kaiserswertherdiakonie

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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