Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home

Prof. Dr. Ingo Fietze

Status: Unknown

Conditions: Patient Compliance

Treatments: Procedure: Automatic Positive Airway Pressure (APAP) initiation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02339597

EA1/306/13

Details and patient eligibility

About

Primary hypothesis:

The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.

Secondary hypothesis:

Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:

Objective measures:

• mask leakage
• pressure
• Apnea-Hypopnea-Index (AHI)

Subjective measures:

• quality of life
• sleepiness

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent from patients after verbally and written informing
• Age between 18 and 80 Years
• obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy

Exclusion criteria

• Intolerance to wear the PAP therapy mask
• sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders
• disabilities who prevents the wear of a therapy mask
• initiated PAP therapy
• pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
• modified Mallampati Score T3 and T4
• participation on clinical studies 4 weeks before start of the study
• known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
• chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
• acute internistic disease
• neuromuscular disease
• condition after Apoplexy
• oncological disease in recent 5 years
• drug/alcohol consumption
• consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

APAP Lab

Experimental group

Description:

standard Initiation of APAP therapy in sleep laboratory.

Treatment:

Procedure: Automatic Positive Airway Pressure (APAP) initiation

APAP Home

Experimental group

Description:

initiation of APAP therapy in homely environment with additional continuous telemetric support.

Treatment:

Procedure: Automatic Positive Airway Pressure (APAP) initiation