Long-term safety and efficacy of positional therapy

• Register: ISRCTN
• Last refreshed on: 20 July 2020
• Main ID: ISRCTN56755910
• Date of registration: 14/05/2018
• Prospective Registration: Yes
• Primary sponsor: Philips
• Public title: Long-term safety and efficacy of positional therapy
• Scientific title: Observational study investigating the long term safety and efficacy of the sleep position trainer in patients with positional obstructive sleep apnea
• Date of first enrolment: 01/09/2018
• Target sample size: 200
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN56755910
• Study type: Observational
• Study design: Long-term multi-centre observational study (Treatment)
• Phase: Not Specified

Countries of recruitment

Belgium, Netherlands, United Kingdom

Contacts

• Name: Olivier Vanderveken

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Positional Sleep Apnea
Respiratory
Sleep Apnea

Intervention(s)

All participants receive the Lunoa Sleep Position Therapy for a minimum two-year period.
Participants are sent home with instructions to use their device nightly. At baseline and each 12-month interval, participants undergo a polysomnography test, complete a battery of questionnaires, are questioned about the occurrence of adverse events and have their compliance data downloaded from the device.

Primary Outcome(s)

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

Secondary Outcome(s)

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
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
3. Compliance is measured from the device download at each 12 month interval
4. Safety is assessed by recording adverse events (AE) at each 12 month interval
5. Comfort and satisfaction of participant is measured using the Visual Analogue Scale (VAS) at each 12 month interval

Secondary ID(s)

EU-2018-002

Nil known

Source(s) of Monetary Support

Philips

Ethics review

Status:
Approval date:
Contact:

Approved 17/12/2018, Ethics committee UZA/UA (Antwerp University Hospital, Ethics committee, Wilrijkstraat 10, 2650, Edegem, Belgium; [phone]; [e-mail]), ref: B300201838420 (= Belgian registration number) and 18/39/421 (internal reference number)

Results

• Results available: Yes
• Date Completed: 01/09/2023