Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?

NCT06973928 | Not Yet Recruiting DMC

• 1 other identifier: 2024-A02761-46
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if changes in quality of life are linked to changes in mouth opening after adenotonsillectomy in a group of children who were diagnosed with Type 1 Obstructive Sleep Apnea (OSA1). The main questions it aims to answer are: Primary Objective:

• Are changes in quality of life linked to improvements in mouth opening after adenotonsillectomy? Secondary Objectives:
• How does quality of life change after adenotonsillectomy, based on different questionnaires about the child's sleep, breathing, behavior, and emotions?
• Is there a link between changes in quality of life and changes in mouth movements after adenotonsillectomy?
• Is there a link between changes in quality of life and changes in sleep quality after adenotonsillectomy?
• How do clinical symptoms change after adenotonsillectomy?
• Are measures of mouth movements linked to measurements of sleep quality after adenotonsillectomy? Participation will require:
• Participating children will have adenotonsillectomy surgery, as suggested by their doctor
• Before and after tonsillectomy, parents of participating children will answer questionnaires related to their child's quality of life and their child's symptoms related to sleep, breathing, behavior, and emotions
• Sleep quality and mouth opening will be evaluated in participating children before and after tonsillectomy

Conditions

Sleep Apnea, Obstructive

Keywords

type 1 obstructive sleep apnea; adenotonsillectomy; mouth opening; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Correlation between change in quality of life and change in mouth opening

  Quality of life (QOL) will be evaluated using two versions of the Pediatric Quality of Life Inventory Parent Proxy Report (PedsQL PPR). The PedsQL PPR 2-4 will be used for participants 3-4 years old, and the PedsQL PPR 5-7 will be used for participants 5-7 years old. For both versions, total scores range from 0-100 points. Higher scores indicate better health related QOL. The JAWAC sensor will be used to measure Mouth Opening in 1/10 millimeters to assess oral breathing during sleep. Oral breathing is a potential cause of sleep apnea in children. Higher measures of Mouth Opening (in millimeters) indicates a greater degree of respiratory disturbance during sleep. The main endpoint analysis (correlation between change in QOL and change in Mouth Opening) will be done using the estimation of the ρ coefficient. A linear regression will be used for the analysis before and after adjustment for confounding variables.

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

Secondary Outcomes (8)

• Changes in quality of life

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

• The correlations between changes in quality of life and changes in other mandibular movement metrics

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

• The relationship between changes in quality of life and changes in polysomnography respiratory disturbance index

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

• Changes in the Sleep-related Breathing Disorder scale

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

• Correlations between mandibular movement and Polysomnography respiratory disturbance index

  Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).

Study Arms (1)

All study participants

This study is a non-randomized, monocentric, prospective trial with a non-blinded single arm. All participants need to have received a surgical indication for adenotonsillectomy to be included in the study. The participants will undergo polysomnography coupled with measurements of mouth opening (using the Jawac) before and after the adenotonsillectomy. Each participant's parent or legal guardian will also complete questionnaires that will provide information about the participant's quality of life and symptoms.

Device: Measures of jaw activity using the Jawac

Interventions

Measures of jaw activity using the Jawac DEVICE

At the inclusion visit (V1), informed consent will be obtained from one parent or legal guardian of each participant, who will then complete questionnaires about their children's quality of life and sleep-related symptoms. Participating children will undergo PSG combined with Jawac measurements of jaw activity. Patients will undergo adenotonsillectomy during the surgical visit (V2). Three months later, at the follow-up visit (V3), patients will again undergo PSG with Jawac measurements, and the same parent or legal guardian will complete the same questionnaires.

All study participants

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pediatric patients between the ages of three and seven years old, who consulted with a surgeon at the study center for potential adenotonsillectomy. To be eligible to participate, patients must be beneficiaries of the French single payer national medical insurance system, be able to attend all scheduled visits and comply with trial procedures, and legal guardians must give informed consent. Full inclusion and exclusion criteria are listed in Table 1. The study center is a private French hospital that, due to the single-payer insurance system in France, should include patients from a range of socioeconomic categories and geographical (urban versus rural) locations.

You may qualify if:

• Age: 3 to 7 years old
• Received a surgical indication for adenotonsillectomy
• Beneficiary of the French single-payer national medical insurance system
• Informed consent given
• Able to attend all scheduled visits and comply with all trial procedures.

You may not qualify if:

• Previous adenotonsillectomy
• Subject has already participated in the current study
• Craniofacial malformation syndrome
• BMI according to age \> 97th percentile
• Previous or current stimulant medication (methylphenidate)
• Current orthodontic treatment
• Asymmetric score of the tonsil with a tonsil Brodsky score of ≤2
• Subject who are in a dependency or employment with the sponsor or the investigator
• Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date

Sponsors & Collaborators

• Groupe Adène: lead
• Clinique Saint Jean, France: collaborator
• Institute of Neurosciences of Montpellier, INSERM U583: collaborator
• UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique: collaborator
• Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

Location

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohammed Akkari, MD

  Clinique Saint Jean, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dany Jaffuel, MD, PhD

CONTACT

09 71 11 79 70; dany.jaffuel@protonmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 15, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)