Obstructive Sleep Apnea of ChildNCT05499455
SleepPOSAtive Trial
A study testing Positional Sleep Belt in people with Obstructive Sleep Apnea of Child, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Positional Sleep Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2022to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 10-90% total sleep time in supine position
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Positional Sleep Belt, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional Sleep BeltDevice
Rematee Positional Sleep Belt
ControlDevice
Control Device
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Active Control Receives: Device: Control |
| Positional Sleep Belt | Experimental | Rematee Positional Sleep Belt Receives: Device: Positional Sleep Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive apnea-hypopnea index
Difference in obstructive apnea-hypopnea index with positional therapy versus control
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
Arousal index
Difference in arousal index with positional therapy versus control
Measured: 3 months
Oxygen desaturation index
Difference in oxygen desaturation index with positional therapy versus control
Measured: 3 months
Percentage of total sleep time supine
Difference in percentage of total sleep time supine with positional therapy versus control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start13 Feb 2022
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499455
- Sponsor's protocol ID
- REB1000077578
- Status last verified
- Jan 2024
- First submitted
- 10 Aug 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40174291
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positional Therapy for the Treatment of Positional Obstructive Sleep Apnea in Children
- ClinicalTrials.gov ID
- NCT05499455
- Acronym / sponsor ID
- REB1000077578
- Conditions
- Obstructive Sleep Apnea of Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: ControlActive Control |
| Positional Sleep Belt | Experimental | Device: Positional Sleep BeltRematee Positional Sleep Belt |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positional Sleep BeltRematee Positional Sleep Belt | Device | Positional Sleep Belt |
| ControlControl Device | Device | Control |
Primary outcome
Obstructive apnea-hypopnea index
Time frame: 3 months
Difference in obstructive apnea-hypopnea index with positional therapy versus control
4 secondary outcomes
Comfort score
Time frame: 3 months
Arousal index
Time frame: 3 months
Oxygen desaturation index
Time frame: 3 months
Percentage of total sleep time supine
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 40174291Xiao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indra Narang, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positional Sleep Belt in people with Obstructive Sleep Apnea of Child, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive apnea-hypopnea index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.