Comparison of Passive Oral Myofunctional Reeducation Using a Flexible Oral Appliance versus Nasal Hygiene Alone in Children with Persistent Obstructive Sleep Apnea Scheduled for Adenotonsillectomy

What this Trial Is About

Obstructive sleep apnea in children is a condition that can lead to serious health problems including effects on heart health, brain development, and overall quality of life. This condition is often caused by enlarged adenoids and tonsils but can also be influenced by factors like obesity and facial structure issues. Researchers are studying whether Passive Oral Myofunctional Reeducation, involving a flexible oral device, is more effective than nasal hygiene alone for children scheduled for adenotonsillectomy. The trial randomly assigns 60 children with obstructive sleep apnea into two groups. One group uses a soft, flexible oral appliance designed to support oral muscles and improve airway function during quiet activities and sleep, alongside nasal hygiene practices. The control group follows nasal hygiene routines alone. The oral device is made of soft material and fits different ages, helping position the tongue and jaw to keep the airway open. Participants will be evaluated before and after the 3-month intervention using a home sleep monitoring device measuring breathing events, oxygen levels, and airflow. Additional assessments include tests of oral muscle strength, facial and orthodontic evaluations, and quality of life questionnaires. Follow-up measurements occur before surgery and three months after to assess changes. Parents will help track nasal hygiene use through diaries. The study lasts through these phases to monitor effects over time.

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