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

Kaiserswerther Diakonie

Status and phase: Unknown; Phase 3

Conditions: Sleep Apnea Syndromes

Treatments: Device: APAP - Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01303198

Kaiserswertherdiakonie

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

CPAP

Active Comparator group

Description:

Use of CPAP as treatment for sleep apnea

Treatment:

Device: APAP - Therapy

APAP

Active Comparator group

Description:

Use of APAP as treatment for sleep apnea

Treatment:

Device: APAP - Therapy