SleepPOSAtive Trial
Study Details
Study Description
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 six months to assess the efficacy of a positional sleep therapy belt compared to a control for treating POSA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 six months 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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Obstructive apnea-hypopnea index [3 months]
Difference in obstructive apnea-hypopnea index with positional therapy versus control
Secondary Outcome Measures
- Comfort score [3 months]
Difference in comfort score with positional therapy versus control
- Arousal index [3 months]
Difference in arousal index with positional therapy versus control
- Oxygen desaturation index [3 months]
Difference in oxygen desaturation index with positional therapy versus control
- Percentage of total sleep time supine [3 months]
Difference in percentage of total sleep time supine with positional therapy versus control
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
OAHI 5-30 events/hour on baseline diagnostic PSG
-
Children meeting the definition of positional OSA on their baseline PSG.
Exclusion Criteria:
-
Current upper respiratory tract infection
-
Co-existing central sleep apnea or chronic respiratory failure
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Requiring supplemental oxygen therapy
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Developmental disability resulting in an inability to independently reposition during sleep
-
Total sleep time on baseline diagnostic PSG < 4 hours
-
Patients adherent to CPAP therapy with more than 6 hours of nightly mean usage over 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5V 1X8 |
Sponsors and Collaborators
- The Hospital for Sick Children
Investigators
- Principal Investigator: Indra Narang, MD, The Hospital for Sick Children
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB1000077578