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Behavioural Intervention

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

N/A

Recruiting

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

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 younger than 18 years old

Must not have

Participants should not present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)

Participants should not present with a craniofacial syndrome nor a severe medical condition with complex medical management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 3 months of intervention, then 3 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using a special mouth device along with nasal hygiene can help children with sleep apnea after they have their tonsils and adenoids removed."

Who is the study for?

This trial is for children with persistent sleep apnea due to enlarged tonsils and adenoids, who are scheduled for surgery (adenotonsillectomy). It's not clear what specific inclusion or exclusion criteria are set.

What is being tested?

The study compares two methods: Passive Oral Myofunctional Reeducation using a soft oral appliance versus nasal hygiene alone. The goal is to see which method better reduces symptoms of obstructive sleep apnea in kids awaiting surgery.

What are the potential side effects?

Potential side effects aren't specified, but the use of a soft oral appliance may cause discomfort, excess saliva production, or gagging. Nasal hygiene typically has minimal side effects like nasal irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show signs of sleep apnea, like snoring or breathing pauses, confirmed by a PSQ score ≥ 0.33.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like Duchenne myopathy or cerebral palsy.

Select...

I do not have a craniofacial syndrome or a severe medical condition requiring complex care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 3 months of intervention, then 3 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 3 months of intervention, then 3 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 3 months of intervention, then 3 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Parameters Changes : Flow Limitation index

Sleep Parameters Changes : Oxygen desaturation index (ODI)

Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI

Secondary study objectives

Oral muscles strength

Reported quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm (Soft Oral Appliance)Experimental 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: Control Arm (Nasal Hygiene)Active Control1 Intervention

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.

0 / 3Eligibility criteria met