Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05499455 |
| Other study ID # |
REB1000077578 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2022 |
| Est. completion date |
April 25, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
The Hospital for Sick Children |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
