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

NCT04425408 | Terminated

• 1 other identifier: B076201941938
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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"

Conditions

Positional Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Comparison of the proportion of supine sleep time without treatment and between the two devices (positional pillow and vibrating belt).

  The percentage of supine sleep on treatment

  5 years

Study Arms (2)

Positional pillow followed by vibrating belt

EXPERIMENTAL

26 patients with positional sleep apnea will be randomized to spend 3 nights using a positional pillow followed by a vibrating belt. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.

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).

Vibrating belt followed by positional pillow

EXPERIMENTAL

26 patients with positional sleep apnea will be randomized to spend 3 nights using a vibrating belt followed by a positional pillow. The time spend on supine position will be monitored on each device and a satisfaction questionnaire as well as a sleep quality questionnaire will be performed after the use of each device.

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).

Interventions

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

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.

Positional pillow followed by vibrating belt; Vibrating belt followed by positional pillow

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Centre hospitalier universitaire Saint Pierre, Rue Haute 322

Brussels, 1000, Belgium

Location

Study Officials

• Marie Bruyneel

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of the Respiratory Unit, Clinical Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: June 11, 2020
• Study Start: February 1, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)