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SleepPOSAtive Trial

NCT05499455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-17

No results posted yet for this study

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

Interventions

DEVICE

Positional Sleep Belt

Rematee Positional Sleep Belt

DEVICE

Control

Control Device

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Indra Narang, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-02-13
Primary Completion
2023-04-25
Completion
2023-04-25

Countries

  • Canada

Study Locations

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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 NCT05499455 on ClinicalTrials.gov