Comparison of 2 Different Positional Therapies for Positional Obstructive Sleep Apnea Syndrome
-
- STATUS
- Recruiting
-
- End date
- Jun 5, 2025
-
- participants needed
- 52
-
- sponsor
- Centre Hospitalier Universitaire Saint Pierre
Summary
The proposed study is a randomized cross over trial assessing the efficacy of two different positional therapies for positional obstructive sleep apnea (POSA).
The effectiveness of the two different therapeutic devices (Positional pillow and vibrating belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea.
The subjective quality of sleep will also be evaluated prior to treatment and following the use of each separate device by means of a "Quality of sleep questionnaire"
Description
Patients with a de novo diagnosis of positional sleep apnoea on a polysomnography performed in our sleep lab will be asked to participate to the study. They should fulfill the Mador definiton of POSA.
A home recording of sleep position with Somnibel Pro will be conduted for 2 consecutive nights. In case of confirmation of supine sleep at home (Mean supine sleep >30% of total sleep time) the patient will be asked to use two different positional therapy devices consecutively (Positional pillow and vibrating belt), 3 nights each, in a random order, with concomitant recording of sleep position with the Somnibel Pro. Global satisfaction questionnaire will be assessed by a simple visual analogic scale (is it easy to use? Is it confortable? Is it efficient on snoring? Is it efficient on sleep apnea? Would you pay for such treatment? Willingness to use it on a long-term basis?) The subjective sleep quality will also be assessed by means of "Sleep quality questionnaire", prior to commencing treatment, and consecutively after 3 nights on each individual therapy.
Statistical analysis:
Efficacy of Positional pillow (Posiform) and vibrating belt (Somnofit) Percentage sleep on back on treatment will be compared to mean percentage sleep on back without treatment, at home, for both devices. Comparison on surrogate AHI based on diagnostic polysomnography, with and without each device. Global satisfaction with the devices will also be compared between devices.
The sleep quality will be compared on the two devices using the "Sleep quality questionnaire".
The sample size of 52 subjects (26 in each arm), has been calculated to obtain a power of 90% and allow a drop out rate of 10%.
Details
| Condition | Positional Obstructive Sleep Apnea |
|---|---|
| Age | 18years - 99years |
| Treatment | Consecutive trial of two different devices for the treatment of positional sleep apnoea, for 3 nights with each device (positional pillow and vibrating belt). |
| Clinical Study Identifier | NCT04425408 |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre |
| Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.