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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

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

Публикации

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Идентификаторы

NCT: NCT06973928 · 2024-A02761-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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