Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
NCT ID: NCT06973928
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-10-15
2026-10-15
Brief Summary
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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
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Detailed Description
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OSA1 is diagnosed and evaluated using the Apnea-Hypopnea Index (AHI), which is considered an indicator of OSA severity. Polysomnography (PSG), the gold standard for measuring AHI, is a time consuming and costly procedure that is impractical for follow-up in a pediatric population. Furthermore, AHI has not been shown to be related to quality of life in children with OSA1. For this reason, interest in using measuring mouth opening, instead of PSG, to evaluate OSA1 has grown. Mouth opening reflects mouth breathing, a common clinical feature of OSA1 that is linked to respiratory effort. In children with OSA1, improvements in mouth breathing have been associated with better behavior, decreased sleepiness, and increased quality of life.
The Jawac© is a novel technology that can be used to reliably measure jaw activity, which is used to evaluate mouth opening, in children. Previous research has shown that changes in respiratory effort-related arousal after adenotonsillectomy were related to changes in mandibular movement. However, no previous research has identified a straightforward, objective biomarker that correlates with quality of life and surgical outcomes in children undergoing adenotonsillectomy. Given the observed links between mouth opening, respiratory effort, and quality of life in pediatric patients, the primary objective of this clinical trial is to determine if changes in quality of life are linked to changes in mouth opening after adenotonsillectomy in a group of children who were diagnosed with OSA1. The secondary aims include studying the relationships between change in quality of life and changes in common Jawac and PSG metrics as well as evaluating variations in quality of life, changes in clinical symptoms, and the relationship between Jawac and PSG metrics in the same population of children who undergo adenotonsillectomy.
STUDY DESIGN AND METHODS This research study is non-randomized, monocentric, prospective, and features a single non-blinded arm due to its exploratory and descriptive nature. During the pre-inclusion visit (V0), surgeons will screen patients for eligibility to participate in the study. 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. The adenotonsillectomy will occur 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. Four months post-surgery, patients will have a follow-up consultation with the surgeon (V4). The study protocol adheres to national guidelines for standard OSA management, with the addition of the questionnaires at V1 and V3, and the PSG with Jaw activity (measured using the Jawac) measurement at V3. Only one extra consultation (V3) is added to the standard patient pathway, thus a low rate of study discontinuation is anticipated. Data from patients who discontinue or deviate from the intervention will be excluded. Adverse events will be documented throughout the study at V1, V2, V3, and V4.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Measures of jaw activity using the Jawac
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.
Interventions
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Measures of jaw activity using the Jawac
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
3 Years
7 Years
ALL
No
Sponsors
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Clinique Saint Jean, France
OTHER
Institute of Neurosciences of Montpellier, INSERM U583
UNKNOWN
UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique
UNKNOWN
Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Groupe Adène
OTHER
Responsible Party
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Principal Investigators
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Mohammed Akkari, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Saint Jean, France
Locations
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Clinique Saint Jean
Saint-Jean-de-Védas, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996 Dec;5(4):251-61. doi: 10.1111/j.1365-2869.1996.00251.x.
Rosen CL, Wang R, Taylor HG, Marcus CL, Katz ES, Paruthi S, Arens R, Muzumdar H, Garetz SL, Mitchell RB, Jones D, Weng J, Ellenberg S, Redline S, Chervin RD. Utility of symptoms to predict treatment outcomes in obstructive sleep apnea syndrome. Pediatrics. 2015 Mar;135(3):e662-71. doi: 10.1542/peds.2014-3099. Epub 2015 Feb 9.
Jordan L, Beydon N, Razanamihaja N, Garrec P, Carra MC, Fournier BP, Vi-Fane B, Kerner S, Felizardo R, Boy-Lefevre ML, De La Dure-Molla M. Translation and cross-cultural validation of the French version of the Sleep-Related Breathing Disorder scale of the Pediatric Sleep Questionnaire. Sleep Med. 2019 Jun;58:123-129. doi: 10.1016/j.sleep.2019.02.021. Epub 2019 Mar 14.
Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
Aubertin G, Akkari M, Andrieux A, Colas des Francs C, Fauroux B, Franco P, Gagnadoux F, de Santerre OG, Grollemund B, Hartley S, Jaffuel D, Lafond L, Schroder CM, Schweitzer C, Charley-Monaca C. Management of obstructive sleep apnea syndrome type 1 in children and adolescents - A French consensus. Arch Pediatr. 2023 Oct;30(7):510-516. doi: 10.1016/j.arcped.2023.06.009. Epub 2023 Aug 2.
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Martinot JB, Le-Dong NN, Denison S, Guenard HJ, Borel JC, Silkoff PE, Pepin JL, Gozal D. Persistent respiratory effort after adenotonsillectomy in children with sleep-disordered breathing. Laryngoscope. 2018 May;128(5):1230-1237. doi: 10.1002/lary.26830. Epub 2017 Aug 22.
Bandyopadhyay A, Slaven JE. Health outcomes associated with improvement in mouth breathing in children with OSA. Sleep Breath. 2021 Sep;25(3):1635-1639. doi: 10.1007/s11325-020-02247-2. Epub 2021 Jan 7.
Leal RB, Gomes MC, Granville-Garcia AF, Goes PS, de Menezes VA. Impact of breathing patterns on the quality of life of 9- to 10-year-old schoolchildren. Am J Rhinol Allergy. 2016 Sep;30(5):147-52. doi: 10.2500/ajra.2016.30.4363.
Liu X, Immanuel S, Pamula Y, Kennedy D, Martin J, Baumert M. Adenotonsillectomy for childhood obstructive sleep apnoea reduces thoraco-abdominal asynchrony but spontaneous apnoea-hypopnoea index normalisation does not. Eur Respir J. 2017 Jan 25;49(1):1601177. doi: 10.1183/13993003.01177-2016. Print 2017 Jan.
Mitchell RB, Garetz S, Moore RH, Rosen CL, Marcus CL, Katz ES, Arens R, Chervin RD, Paruthi S, Amin R, Elden L, Ellenberg SS, Redline S. The use of clinical parameters to predict obstructive sleep apnea syndrome severity in children: the Childhood Adenotonsillectomy (CHAT) study randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):130-6. doi: 10.1001/jamaoto.2014.3049.
da Silva Gusmao Cardoso T, Pompeia S, Miranda MC. Cognitive and behavioral effects of obstructive sleep apnea syndrome in children: a systematic literature review. Sleep Med. 2018 Jun;46:46-55. doi: 10.1016/j.sleep.2017.12.020. Epub 2018 Feb 9.
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Other Identifiers
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2024-A02761-46
Identifier Type: -
Identifier Source: org_study_id
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