MedTrace Logo

Comparison of 2 Different Positional Therapies for Positional Obstructive Sleep Apnea Syndrome

NCT04425408 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-05-07

No results posted yet for this study

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"

Conditions

  • Positional Obstructive Sleep Apnea

Interventions

DEVICE

Consecutive trial of two different devices for the treatment of positional sleep apnoea, for 3 nights with each device (positional pillow and vibrating belt).

Patients will be randomly allocated to use either a positional pillow or a vibrating belt for three consecutive nights at home followed by three nights with the other device.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • Marie Bruyneel · Centre Hospitalier Universitaire Saint Pierre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425408 on ClinicalTrials.gov