SleepPOSAtive Trial

NCT05499455 | Completed

• 1 other identifier: REB1000077578
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized crossover trial of children diagnosed with positional obstructive sleep apnea (POSA) on a baseline polysomnogram (PSG). Participants will undergo two further PSGs in random order over 4 weeks to assess the efficacy of a positional sleep therapy belt compared to a control for treating POSA.

Conditions

Obstructive Sleep Apnea of Child

Outcome Measures

Primary Outcomes (1)

• Obstructive apnea-hypopnea index

  Difference in obstructive apnea-hypopnea index with positional therapy versus control

  3 months

Secondary Outcomes (4)

• Comfort score

  3 months

• Arousal index

  3 months

• Oxygen desaturation index

  3 months

• Percentage of total sleep time supine

  3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Active Control

Device: Control

Positional Sleep Belt

EXPERIMENTAL

Rematee Positional Sleep Belt

Device: Positional Sleep Belt

Interventions

Positional Sleep Belt DEVICE

Rematee Positional Sleep Belt

Positional Sleep Belt

Control DEVICE

Control Device

Control

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Consent provided by patient or caregiver. If consent provided by caregiver, assent will be provided from patient whenever possible.
• Children aged 4 to 18 years old
• A diagnostic polysomnogram with obstructive apnea-hypopnea index of 5-30 events/hour.
• Diagnosed with positional obstructive sleep apnea on baseline diagnostic polysomnogram as defined as:
• supine-to-nonsupine obstructive apnea-hypopnea index ratio of 2 or greater
• % total sleep time in supine position

You may not qualify if:

• Current upper respiratory tract infection
• Requires bilevel positive airway pressure in the opinion of the child's physician (e.g. diagnosed with co-existing central sleep apnea, chronic respiratory failure, or bradypnea for age)
• Requiring oxygen therapy
• Unable to reposition independently
• Total sleep time \< 4 hours on diagnostic polysomnogram
• Unable to tolerate electroencephalogram montage on diagnostic polysomnogram
• Adherent to continuous positive airway pressure therapy (\> 6 hours nightly usage)
• Distance travelled to study site \> 200 km

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V 1X8, Canada

Location

Related Publications (1)

• Xiao L, Baker A, Massicotte C, Reyna ME, Shi J, Wolter NE, Propst EJ, Mahant S, Amin R, Parekh RS, Narang I. Positional therapy for the treatment of positional obstructive sleep apnea in children: A randomized controlled crossover trial. Sleep Med. 2025 Jun;130:48-55. doi: 10.1016/j.sleep.2025.03.022. Epub 2025 Mar 28.

  PMID: 40174291 DERIVED

Study Officials

• Indra Narang, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: February 13, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)