Patient Compliance
Conditions
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
Interventions
PROCEDUREAutomatic Positive Airway Pressure (APAP) initiation
Sponsors
ResMed
Prof. Dr. Ingo Fietze
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of usage hours of of positive airway pressure therapy per night | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index [1 / hour of sleep) | 6 month |
Other
| Measure | Time frame |
|---|---|
| Quality of Life | 6 month |
Countries
Germany
Contacts
Primary ContactIngo Fietze, MD, PhD
Outcome results
None listed