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Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial

Key facts

Who runs it
Université de Montréal
Where
Canada1 site in 1 countryChoose a country to see its sites
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?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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.

Read full original descriptionShow less

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06634264, who can take part
Record updated
9 October 2024