Sleep Apnea, ObstructiveJawChildNCT06973928
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
An observational study of Sleep Apnea, Obstructive, run by Groupe Adène at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Measures of jaw activity using the Jawac
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Saint Jean
Saint-Jean-de-Védas, 34430
Régis Lopez, MD, 04 67 01 01 01, regislopez66@gmail.com
About this study
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
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:
Read more
•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
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Measures of jaw activity using the Jawac
- Keywords
- type 1 obstructive sleep apnea, adenotonsillectomy, mouth opening, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of jaw activity using the JawacDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Measures of jaw activity using the Jawac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).
Secondary outcomes (8)
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)
Measured: 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
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
Measured: 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
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
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).
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.
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).
Correlations between mandibular movement and Polysomnography respiratory disturbance index
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).
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.
Correlation analyses will be conducted
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3).
Changes in acute sleep disturbances
The Sleep Disturbance Scale for Children (SDSC) (separate versions for 3-4 and for 5-7 year olds) has 26 items, scored from 1-5 (maximmum score 130, minimum score 1). Higher scores indicate more acute sleep disturbances.
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)
Changes in emotional and behavioral difficulties
The Strengths and Difficulties Questionnaire (SDQ) (separate versions for 3-4 and 5-7 year olds) has 25 items divided into 5 scales (score range: 0-40). Higher total scores suggest significant emotional and behavioral difficulties.
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)
Severity Hierarchy Score for Respiratory Symptoms
The Severity Hierarchy Score (SHS) will be used to rank respiratory symptoms from least to most severe. It does not have defined maximum and minimum scores.
Measured: Change from the inclusion visit (V1) to three months after adenotonsillectomy (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Adène
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Saint Jean, France, Institute of Neurosciences of Montpellier, INSERM U583, UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique, Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Mohammed Akkari, MD, Principal investigator, Clinique Saint Jean, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973928
- Sponsor's protocol ID
- 2024-A02761-46
- Acronym
- JawChild
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9255702Bruni 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.
PubMed 9065877Rosen 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.
PubMed 25667240Jordan 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.
PubMed 31146124Chervin 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.
PubMed 10733617Varni 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.
PubMed 11468499Aubertin 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.
PubMed 37537084Costain 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.
PubMed 38624480Martinot 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.
PubMed 28833232Bandyopadhyay 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.
PubMed 33411187Leal 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.
PubMed 27657891Liu 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.
PubMed 27811072Mitchell 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.
PubMed 25474490da 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.
PubMed 29773210Katz ES, D'Ambrosio CM. Pathophysiology of pediatric obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):253-62. doi: 10.1513/pats.200707-111MG.
PubMed 18250219
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06973928
- Acronym / sponsor ID
- JawChild / 2024-A02761-46
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- type 1 obstructive sleep apnea, adenotonsillectomy, mouth opening, Polysomnography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Groupe AdèneUniversity, hospital or other
- Collaborators
- Clinique Saint Jean, France, Institute of Neurosciences of Montpellier, INSERM U583, UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique, Service d'Information Médicale, Épidémiologie et Données de Santé (SIMED), CHU Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Device: Measures of jaw activity using the JawacThis 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures of jaw activity using the JawacAt 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. | Device | All study participants |
Primary outcome
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).
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 9255702Goodman 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.
- Background: PubMed 9065877Bruni 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.
- Background: PubMed 25667240Rosen 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.
- Background: PubMed 31146124Jordan 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.
- Background: PubMed 10733617Chervin 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.
- Background: PubMed 11468499Varni 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.
- Background: PubMed 37537084Aubertin 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.
- Background: PubMed 38624480Costain 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.
- Background: PubMed 28833232Martinot 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.
- Background: PubMed 33411187Bandyopadhyay 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.
- Background: PubMed 27657891Leal 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.
- Background: PubMed 27811072Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Akkari, MD principal investigator
Clinique Saint Jean, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Groupe Adène at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dany Jaffuel, MD, PhD (09 71 11 79 70, dany.jaffuel@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973928, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.