ong-term safety and efficacy of positional therapy

Not Applicable

• Conditions: Positional Sleep Apnea; Respiratory; Sleep Apnea

• Registration Number: ISRCTN56755910
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Last Update Posted: 20 July 2020
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Adult patients with a diagnosis of supine-dependent OSA defined as;
1.1. an AHI supine = 2x AHI non supine, or,
1.2. AHI non-supine < 10/h and an AHI supine = 10/h,
1.3. and 10 – 90 % supine sleep during PSG.

Exclusion Criteria

1. A female of child-bearing potential that is pregnant or intends to become pregnant.
2. Any unstable or severe medical condition of any organ system that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results.
3. Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results.
4. Oxygen use
5. The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy)
6. Excessive alcohol consumption (>21 drinks/week)
7. The use of any illegal drug(s), per subject report.
8. Night or rotating shift work.
9. Severe claustrophobia.
10. Shoulder, neck, or back complaints that restrict sleeping position.
11. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
12. Driving risk: any car accident or near miss accident caused by sleepiness in the last 12 months and upon PI discretion

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Apnea–Hypopnea (AHI) obtained from a polysomnography (PSG) sleep study at baseline and each 12 month interval.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Efficacy of the device is measured using Epworth Sleepiness Scale (ESS), Pichot Fatigue Scale, Health and Anxiety Scale (HAD) at baseline and each 12 month interval<br> 2. Quality of Life is measured using Functional Outcomes of Sleep Questionnaire (FOSQ) and Short-Form 36 questionnaires (SF-36) at baseline and each 12 month interval<br> 3. Compliance is measured from the device download at each 12 month interval<br> 4. Safety is assessed by recording adverse events (AE) at each 12 month interval<br> 5. Comfort and satisfaction of participant is measured using the Visual Analogue Scale (VAS) at each 12 month interval<br>