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
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
Previous adenotonsillectomy
Subject has already participated in the current study
Craniofacial malformation syndrome
BMI according to age > 97th percentile
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.
Cohort
Prospective
Measures of jaw activity using the Jawac
DeviceAt 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.
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.
Changes in 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 same parent or legal guardian will complete the PedsQL at inclusion (V1) and three months after adenotonsillectomy (V3)
The correlations between changes in quality of life and changes in other mandibular movement metrics
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 mandibular movement (MM) measures that will be evaluated using the Jawac are: large MM (MML): the number of MM amplitudes ≥0.3 mm from peak to peak during ≥two respiratory cycles; Sharp MM (MMS): the number of sudden large MMs (amplitude \>1mm and/or amplitude ≥200% of the previous and/or the ensuing MM amplitude) during one respiratory cycle; Mandibular movement opening (MMO): how wide the mouth opens (in mm) during MM; Time durations during non-rapid eye movement sleep when mandibular movement is higher than 0.4 mm (tMM0.4), 0.3 mm (tMM0.3), and 0.2 mm (tMM0.2). Correlation analyses will be conducted
The relationship between changes in quality of life and changes in polysomnography respiratory disturbance index
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. Polysomnography respiratory disturbance index (PSG-RDI), which measures the number of abnormal breathing events per hour of sleep, will be evaluated as defined by the American Academy of Sleep Medicine 2018. PSG-RDI defines sleep apnea severity as follows: normal: \<5 events/hr; mild: ≥5 but \<15 events/hr; moderate: ≥15 but \<30 events/hr; severe: ≥30 events/hr. A linear regression will be used for the analysis before and after adjustment for confounding variables
Changes in the Sleep-related Breathing Disorder scale
Clinical symptoms will be evaluated using The Sleep-related Breathing Disorder scale of the Pediatric Sleep Questionnaire (PSQ), which consists of 22 items. The score is the mean response on non-missing items, which can vary from 0 to 1. Higher scores reflect high risk for a pediatric sleep-related breathing disorder.
Click on the lead sponsor to view all of their trials.
Groupe Adène
Lead sponsor
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
