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

Official title

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

Overview

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

Detailed description

STUDY BACKGROUND AND OBJECTIVES Obstructive Sleep Disordered Breathing (oSDB) encompasses a range of abnormal breathing patterns during sleep, from snoring to complete airway obstruction, caused by increased upper airway resistance and pharyngeal collapsibility. Although often considered an adult disease, oSDB also occurs in children, and has been linked to metabolic, cardiovascular, and neurocognitive morbidity, and lower quality of life in pediatric patients. This study focuses on children who have Type 1 Obstructive Sleep Apnea (OSA1), a condition where a person's airway can become blocked repeatedly during sleep. The common treatment for OSA1 is adenotonsillectomy.

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.

Interventions

• Device 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

Primary outcome measures

• Correlation between change in quality of life and change in mouth opening [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).]

Secondary outcome measures (8)

• Changes in quality of life [Time frame: 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 [Time frame: 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 [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).]
• Changes in the Sleep-related Breathing Disorder scale [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).]
• Correlations between mandibular movement and Polysomnography respiratory disturbance index [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).]
• Changes in acute sleep disturbances [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)]
• Changes in emotional and behavioral difficulties [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)]
• Severity Hierarchy Score for Respiratory Symptoms [Time frame: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Clinique Saint Jean — Saint-Jean-de-Védas

Publications

• 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. PMID 9255702
• 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. PMID 9065877
• 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. PMID 25667240
• 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. PMID 31146124
• 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. PMID 10733617
• 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. PMID 11468499
• 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. PMID 37537084
• Costain G, Cohn RD, Malkin D. Precision Child Health: an Emerging Paradigm for Paediatric Quality and Safety. Curr Treat Options Pediatr. 2020;6(4):317-324. doi: 10.1007/s40746-020-00207-2. Epub 2020 Aug 25. PMID 38624480

Identifiers

NCT: NCT06973928 · 2024-A02761-46

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗