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New treatment option for Obstructive Sleep Apnea
Official title Positional Therapy for Childhood Obstructive Sleep Apnoea
ClinicalTrials.gov ID: NCT06453018
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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)...
- Informed consent from a parent or a legal guardian
You likely can't join if
- Severe OSA with an OAHI ≥ 30 events/hour that conventional treatment such as adenotonsillectomy and CPAP should be considered before positional...
- 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...
See the full eligibility criteria
- 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...
- Informed consent from a parent or a legal guardian
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.