SleepPOSAtive Trial

Positional Therapy for the Treatment of Positional Obstructive Sleep Apnea in Children

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Child
• Intervention / Treatment: Device: Control; Device: Positional Sleep Belt

Detailed Description

Obstructive sleep apnea (OSA) is highly prevalent, and the gold standard therapy is continuous positive airway pressure (CPAP) for persistent OSA. Although CPAP is highly efficacious, long-term effectiveness is limited by poor adherence rates. Given the burden of untreated OSA in children, novel alternative therapies that are effective, acceptable and comfortable are urgently required.

OSA is characterized by recurrent obstruction of the upper airway associated with intermittent hypoxia and chronic sleep deprivation. OSA occurs in 1-4% of healthy children and in up to 80% of children with medical complexity (e.g. Down syndrome). It has significant health, societal, and economic impacts. CPAP is the gold standard therapy for persistent OSA but is poorly tolerated.

There is distinct clinical phenotype of OSA characterized by the predominance of obstructions in supine position, as measured by the obstructive apnea-hypopnea index (OAHI) on polysomnography (PSG). Up to half of children with OSA meet criteria for this phenotype which is termed positional OSA. Positional sleep belts that prevent children from adopting supine position may be beneficial for treating OSA but have not yet been studied in children.

The primary aim of this study is to assess the efficacy of a body positional sleep belt for the treatment of moderate to severe positional OSA in a paediatric population. This is a randomized crossover trial of children aged 4-18 years diagnosed with positional OSA. Participants will undergo two PSGs in random order over 4 weeks with a control and positional device therapy to assess treatment efficacy. Perceived comfort will be evaluated with surveys.

This novel research addresses a critical knowledge gap regarding the rigorous evaluation of alternative therapies beyond CPAP for managing OSA. Positional therapy has the potential to change clinical practice as an effective, cost-efficient, and non-invasive treatment option for children with positional OSA, particularly for children intolerant of CPAP.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Consent provided by patient or caregiver. If consent provided by caregiver, assent will be provided from patient whenever possible.
2. Children aged 4 to 18 years old
3. A diagnostic polysomnogram with obstructive apnea-hypopnea index of 5-30 events/hour.

4. Diagnosed with positional obstructive sleep apnea on baseline diagnostic polysomnogram as defined as:

   1. supine-to-nonsupine obstructive apnea-hypopnea index ratio of 2 or greater
   2. 10-90% total sleep time in supine position

Exclusion Criteria:

1. Current upper respiratory tract infection
2. 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)
3. Requiring oxygen therapy
4. Unable to reposition independently
5. Total sleep time < 4 hours on diagnostic polysomnogram
6. Unable to tolerate electroencephalogram montage on diagnostic polysomnogram
7. Adherent to continuous positive airway pressure therapy (> 6 hours nightly usage)
8. Distance travelled to study site > 200 km

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Active Control	Device: Control; Control Device
Experimental: Positional Sleep Belt; Rematee Positional Sleep Belt	Device: Positional Sleep Belt; Rematee Positional Sleep Belt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstructive apnea-hypopnea index	Difference in obstructive apnea-hypopnea index with positional therapy versus control	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arousal index	Difference in arousal index with positional therapy versus control	3 months
Oxygen desaturation index	Difference in oxygen desaturation index with positional therapy versus control	3 months
Percentage of total sleep time supine	Difference in percentage of total sleep time supine with positional therapy versus control	3 months
Comfort score	Difference in comfort score with positional therapy versus control. This is measured on a numeric rating scale with a score range of 0-10, with higher scores indicating decreased comfort.	3 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Indra Narang, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: REB1000077578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No