Obstructive Sleep ApneaNCT06453018
Positional Therapy for Childhood Obstructive Sleep Apnoea
A study testing Positional device, Rematee Bumper Belt or Night Shift in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder associated with a wide spectrum of morbidities, including neurobehavioural, cardiovascular, and metabolic complications. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Positional device, Rematee Bumper Belt or Night Shift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jul 2024to 31 Dec 2025
- Phase
- Interventional
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-17 years
- Diagnosis of positional OSA on a baseline diagnostic polysomnography (PSG), defined as 1) an overall OAHI ≥ 5 events/hour (moderate-to-severe OSA), 2) a supine OAHI greater than or equal to two times of the non-supine OAHI, and 3) at least 30 minutes or 10% of total sleep time of supine sleep, and at least 30 minutes or 10% of total sleep time of non-supine sleep observed in the diagnostic PSG (9-11)
- Informed consent from a parent or a legal guardian
Who cannot join
- Severe OSA with an OAHI ≥ 30 events/hour that conventional treatment such as adenotonsillectomy and CPAP should be considered before positional therapy, severe disease warranting urgent referral for treatment
- Genetic, syndromal, or metabolic disease
- Congenital or acquired neuromuscular disease
- Craniofacial abnormalities
- Structural or congenital heart disease
- Severe chronic respiratory disease that may affect the oxygen saturation or ventilation during sleep and positional therapy is regarded as not appropriate
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- Autism spectrum disorder or severe developmental delay (developmental or functional age <66% of chronological age (16) that could affect the tolerance to the positional device
- Current treatment with positive airway pressure
- Skeletal abnormalities or other conditions that restrict the sleeping position
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder associated with a wide spectrum of morbidities, including neurobehavioural, cardiovascular, and metabolic complications. Positional OSA (POSA) is one of the distinct clinical phenotypes in which obstructive respiratory events occur predominantly while sleeping in the supine position. As the majority of the OSA events in POSA occur in the supine position, positional therapy has become a reasonable non-invasive treatment strategy.
The primary objectives of our study are 1) To investigate the feasibility of positional therapy in children with positional OSA; 2) To investigate the efficacy of positional therapy in children with positional OSA.
Read more
Hypothesis to be tested: 1) Positional therapy is feasible in children with positional OSA.
- Positional therapy is efficacious in children with positional OSA by improving sleep related symptoms and quality of life.
Design and subjects: A prospective case-control study. 20 children aged 6 to 17 years of age with positional OSA (POSA) will be invited to join the study.
Primary and secondary outcome measures: The changes in sleep-related symptoms, quality of life and behavioral measures between the baseline and 3 months after treatment with a positional device therapy. Adherence to the positional device.
Statistical Analysis: Continuous data will be presented as mean and standard deviation or median with the interquartile range depending on its distribution, whereas categorical data will be shown as proportions. Changes in outcome measures between the baseline and 3 months after using the positional device will be compared using Wilcoxon signed rank tests. Within-subject differences in the outcome parameters will be tested by paired t-tests, McNemar tests, and marginal homogeneity tests for continuous, dichotomous, and categorical data respectively.
Expected results: Positional therapy is practicable and efficacious in children with positional OSA by improving sleep related symptoms.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Positional device, Rematee Bumper Belt or Night Shift
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional device, Rematee Bumper Belt or Night ShiftDevice
Positional device, Rematee Bumper Belt (Rematee, Blaine, Washington), or Night Shift (Advanced Brain Monitoring) on chest belt, will be used as the intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Positional therapy Receives: Device: Positional device, Rematee Bumper Belt or Night Shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep related symptoms
Questionnaire-based assessments on sleep symptoms by Pediatric Sleep Questionnaire (PSQ): The PSQ consists of 22 items, and responses are scored as "yes" = 1, "no" = 0, and "don't know" = missing. The mean response on non-missing items is the score, which can range from 0 to 1. Higher scores on the PSQ indicate a greater likelihood of sleep-related problems. Specifically, a score greater than 0.33 (33% of questions answered positively) suggests a high risk for pediatric sleep-related breathing disorders
Measured: 3 months
Daytime sleepiness assessment 1
Questionnaire-based assessments on sleep symptoms by Pediatric Daytime Sleepiness Scale (PDSS): The PDSS consists of 8 questions, each scored on a 5-point Likert scale ranging from 0 to 4. Therefore, the total score can range from 0 to 32. Higher scores on the PDSS indicate greater daytime sleepiness.
Measured: 3 months
Daytime sleepiness assessment 2
Questionnaire-based assessments on sleep symptoms by modified Epworth Sleepiness Scale for children and adolescents (ESS-CHAD): The ESS-CHAD consists of 8 questions, each scored on a scale from 0 to 3. Therefore, the total score can range from 0 to 24. Higher scores on the ESS-CHAD indicate greater daytime sleepiness.
Measured: 3 months
Secondary outcomes (3)
Quality of life measure
Questionnaire-based assessments on quality of life measure by Obstructive Sleep Apnoea-18 questionnaire: OSA-18. is a quality of life questionnaire used to assess the impact of obstructive sleep apnea on children. It consists of 18 items, each scored on a scale from 1 to 7. Therefore, the total score can range from 18 to 126. Higher scores on the OSA-18 indicate a worse outcome, reflecting a greater negative impact on the child's quality of life due to obstructive sleep apnea. Specifically: Scores below 60 suggest a mild impact; Scores between 60 and 80 suggest a moderate impact; Scores above 80 suggest a severe impact.
Measured: 3 months
Behavioural outcomes
Questionnaire-based assessments on behavioural outcomes using child behavior checklist CBCL. The CBCL consists of 113 items, each scored on a 3-point scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true). The total score can range from 0 to 226. Higher scores on the CBCL indicate more behavioral and emotional problems.
Measured: 3 months
Adherence to intervention
Diary-based assessments on adherence or device recorded usage if using Night Shift
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 posted11 Jun 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Children aged 6 to 17 years of age with positional OSA (POSA) will receive the positional therapy.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Kate Ching Ching Chan, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453018
- Sponsor's protocol ID
- POSAv1.0
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided