Obstructive Sleep Apnea of Child study: Soft Oral Appliance
Official title Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06634264
What this study is testing
- What it's testing
- The study wants to see if a flexible oral appliance (passive myofunctional reeducation) works better than just nasal hygiene for children with sleep apnea.
- Who it's for
- Children who have obstructive sleep apnea and are about to have their adenoids and tonsils removed.
- What's involved
- Participants will either use a flexible oral appliance or follow a nasal hygiene routine, and will have visits and tests to track their sleep and breathing.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 14
You may be able to join if
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric...
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).
You likely can't join if
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- receive orthodontic therapy during the study
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate...
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication...
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
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, but 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, 4 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.