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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CPAP

Use of CPAP as treatment for sleep apnea

Group Type ACTIVE_COMPARATOR

APAP - Therapy

Intervention Type DEVICE

automatic positive pressure therapy

APAP

Use of APAP as treatment for sleep apnea

Group Type ACTIVE_COMPARATOR

APAP - Therapy

Intervention Type DEVICE

automatic positive pressure therapy

Interventions

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APAP - Therapy

automatic positive pressure therapy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No