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

Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01303198

Enrollment

Registered

2011-02-24

Start date

2001-06-30

Completion date

2011-04-30

Last updated

2011-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

CPAP, APAP, sleep apnea

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).

Interventions

DEVICEAPAP - Therapy

automatic positive pressure therapy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
AHI- score (apnea- hypopnea- index)	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

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

Countries

Germany

Contacts

Primary ContactHartmut Grüger

grueger@kaiserswerther-diakonie.de0211 4093519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026