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Soft Oral Appliance for Obstructive Sleep Apnea (PERSIST-B Trial)

N/A
Waitlist Available
Led By Nelly Huynh, PhD
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

PERSIST-B Trial Summary

Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).

Eligible Conditions
  • Obstructive Sleep Apnea

PERSIST-B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Sleep Parameters Changes : Flow Limitation index
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Secondary outcome measures
Nasal Resistance
Oral muscles strength
Quality of Life

PERSIST-B Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Soft Oral ApplianceExperimental Treatment1 Intervention
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.
Group II: Myofunctional Oral ExercicesActive Control1 Intervention
Parents and participants of this group will receive instructions for nasal and oral myo-functional exercises, to perform at home each day, for 5 to 10 minutes. A booklet (measure of adherence) and an Phone application for Android/Apple with descriptions/videos of those exercices will be given to them. These exercises will include nasal hygiene procedures, nasal cartilage exercices, lingual posture rehabilitation exercises, lip tone enhancement exercises, and swallowing rehabilitation exercises.
Group III: Control GroupActive Control1 Intervention
Parents and Participants of this group will be reminded the nasal hygiene procedures (application of saline in each nostril three times a day), and given a diary to report daily use.

Find a Location

Who is running the clinical trial?

Université de MontréalLead Sponsor
214 Previous Clinical Trials
102,759 Total Patients Enrolled
St. Justine's HospitalOTHER
196 Previous Clinical Trials
79,017 Total Patients Enrolled
Nelly Huynh, PhDPrincipal InvestigatorUniversité de Montréal, Montréal, Québec, Canada
3 Previous Clinical Trials
158 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea
Nelly Huynh 2017. "Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03061019.
~1 spots leftby Apr 2025
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