Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
Key facts
- Who runs it
- Université de Montréal
- Where
- Montreal, CanadaSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 20 Mar 2024
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Soft Oral Appliance
- Record updated
- 9 October 2024
Who can take part
- Age
- 4 years to 14 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- participants must:
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric Sleep Questionnaire (PSQ) , greater than or equal to 0.33- This questionnaire comprises twenty-two Questions and has a good sensitivity (83%) and specificity (87%) in screening for pediatric sleep apnea
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more)
Who cannot take part
- receive orthodontic therapy during the study
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- participants should not:
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 14 years old?
Where in Canada
- CHU Sainte Justine, Université de MontréalMontreal, CanadaContact: Nelly Huynh, PhDTaking people
About the trial
What the trial wants to find out
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy.
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This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control group), in a population of children scheduled for adenotonsillectomy.
The 2 groups in the trial
- Intervention Arm (Soft Oral Appliance)Treatment being tested
Parents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth.
Treatment: Soft Oral Appliance
- Control Arm (Nasal Hygiene)No study treatment, for comparison
Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06634264, who can take part
- Record updated
- 9 October 2024