Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home
Not Applicable
- Conditions
- Patient Compliance
- Interventions
- Procedure: Automatic Positive Airway Pressure (APAP) initiation
- Registration Number
- NCT02339597
- Lead Sponsor
- Prof. Dr. Ingo Fietze
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 224
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APAP Home Automatic Positive Airway Pressure (APAP) initiation initiation of APAP therapy in homely environment with additional continuous telemetric support. APAP Lab Automatic Positive Airway Pressure (APAP) initiation standard Initiation of APAP therapy in sleep laboratory.
- Primary Outcome Measures
Name Time Method Number of usage hours of of positive airway pressure therapy per night 6 month
- Secondary Outcome Measures
Name Time Method Apnea Hypopnea Index [1 / hour of sleep) 6 month
Trial Locations
- Locations (1)
Charite-Universitaetsmedizin Berlin, Center for Sleep Medicine
🇩🇪Berlin, Germany