Clinical trial NCT04425408: Comparison of 2 Different Positional Therapies for Positional Obstructive Sleep Apnea Syndrome
Official title: Randomized Cross Over Trial Assessing the Efficacy of Two Different Positional Therapies for Positional Obstructive Sleep Apnea (POSA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Positional Obstructive Sleep Apnea
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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"

Detailed 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%.

Eligibility criteria: Inclusion Criteria:

* Adult patients able to give writtent consent with a de novo diagnosis of positional sleep apnoea according to a polysomnograph.

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Comparison of the proportion of supine sleep time without treatment and between the two devices (positional pillow and vibrating belt).
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre hospitalier universitaire Saint Pierre, Rue Haute 322
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Marie Bruyneel
role: PRINCIPAL_INVESTIGATOR
References: