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

Primary Purpose

Sleep Apnea Syndromes

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
APAP - Therapy
Sponsored by
Kaiserswerther Diakonie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring CPAP, APAP, sleep apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florence-Nightingale-KrankenhausRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CPAP

APAP

Arm Description

Use of CPAP as treatment for sleep apnea

Use of APAP as treatment for sleep apnea

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of device-using hours
Number of device-using hours as a means to assess patient compliance with the treatment

Full Information

First Posted
February 22, 2011
Last Updated
February 23, 2011
Sponsor
Kaiserswerther Diakonie
Collaborators
ResMed Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01303198
Brief Title
Autoset T Versus CPAP Therapy, a Comparison of Titration and Therapy
Official Title
Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2001 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kaiserswerther Diakonie
Collaborators
ResMed Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
CPAP, APAP, sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
Use of CPAP as treatment for sleep apnea
Arm Title
APAP
Arm Type
Active Comparator
Arm Description
Use of APAP as treatment for sleep apnea
Intervention Type
Device
Intervention Name(s)
APAP - Therapy
Intervention Description
automatic positive pressure therapy
Primary Outcome Measure Information:
Title
AHI- score (apnea- hypopnea- index)
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of device-using hours
Description
Number of device-using hours as a means to assess patient compliance with the treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hartmut Grüger
Phone
0211 4093519
Email
grueger@kaiserswerther-diakonie.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Grueger, Arzt
Organizational Affiliation
Diakonie Kaiserswerth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florence-Nightingale-Krankenhaus
City
Düsseldorf
State/Province
Nordrhein Westphalen
ZIP/Postal Code
40489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hartmut Grüger
Phone
0211 4093519

12. IPD Sharing Statement

Learn more about this trial

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

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