Sleep position therapy for mild to moderate position-dependent obstructive sleep apnea

Not Applicable

• Conditions: G47.31

• Registration Number: DRKS00033048
• Lead Sponsor: ehrstuhl für Medizinmanagement, Universität Duisburg-Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

mild to moderate, supine-dependent obstructive sleep apnoea (total AHI 5 - < 30/h)
- AHI at least twice as high in supine position compared to non-supine position
- at least 30% of total sleep time in supine position
- AHI in non-supine position < 10/h
- Indication for nocturnal positive pressure therapy with relevant daytime sleepiness (ESS > 10 points)

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)