G47.31
Conditions
Interventions
Group 1: positive airway pressure therapy (12 weeks) - wash-out (2 weeks) - sleep position therapy (12 weeks) (cross-over design)
Group 2: sleep position therapy (12 weeks) - wash-out (2 weeks) - posi
Sponsors
Lehrstuhl für Medizinmanagement, Universität Duisburg-Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - mild to moderate, supine-dependent obstructive sleep apnoea (total AHI 5 - 10 points)
Exclusion criteria
Exclusion criteria: - previous or current treatment for sleep apnoea with devices or surgery - current oxygen therapy - current pregnancy - active employment as a professional driver - taking sedative or vigilance-enhancing medication - unstable medical condition that, in the opinion of the investigator, may interfere with participation in the study - presence of other relevant sleep disorders affecting daytime sleepiness - excessive alcohol consumption (> 3 drinks/day) - drug use - severe claustrophobia - musculoskeletal problems that limit sleeping in a lateral position - inability to understand the study and patient information leaflet - Patients with an active, cardiac device (pacemaker, ACID, CRT, ...) - use of other medical devices (e.g. implanted aggregates, neurostimulation devices, or similar) that may be affected by the mild vibration stimuli to the chest from the sleep position trainer - health condition that requires sleeping in the supine position (e.g. due to shoulder or back surgery or osteoarthritis) - sleeping in an upright position (e.g. due to the use of more than two pillows)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| subjective daily sleepiness according to Epworth Sleepiness Scale (measured at screening, end of treatment phase 1, start of treatment phase 2, end of treatment phase 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| - sleep quality according to the Pittsburgh Sleep Quality Index (measured at start of treatment phase 1, end of treatment phase 1, start of treatment phase 2, end of treatment phase 2) - objective sleep parameters from polysomnography (including total AHI) (measured at screening, start of treatment phase 1, end of treatment phase 1, start of treatment phase 2, end of treatment phase 2) - health-related quality of life according to the Functional Outcomes of Sleep Questionnaire (measured at start of treatment phase 1, end of treatment phase 1, start of treatment phase 2, end of treatment phase 2) - health-related quality of life according to EQ-5D-5L (measured at start of treatment phase 1, end of treatment phase 1, start of treatment phase 2, end of treatment phase 2) - adverse events according to standardized severity classification (measured during treatment phase 1, at the end of treatment phase 1, during treatment phase 2, at the end of treatment phase 2) and therapy discontinuations due to adverse events - therapy utilization data (measured at end of treatment phase 1, end of treatment phase 2) | — |
Countries
Germany
Contacts
Public ContactAlexandra Nam-Mi Spillner
Alcedis GmbH
Outcome results
None listed