Use of a Mandibular Advancement Appliance in Children With Obstructive Sleep Apnea
Background:
Obstructive sleep apnea (OSA) is a condition where the airway becomes partly or fully blocked during sleep. OSA disrupts normal sleep. In children, if left untreated, OSA can affect development and cause serious health issues. Researchers want to see if a device (DynaFlex Dorsal Accu-fit) worn in the mouth can treat OSA in children.
Objective:
To test the DynaFlex Dorsal Accu-fit in children with OSA.
Eligibility:
Children aged 6 to 17 years with mild to moderate OSA.
Patients with parents or caregivers that cannot understand and/or speak English will be excluded because this study requires care giver-directed at-home device titration, safety monitoring, weekly reporting, and completion of study questionnaires, and the study materials and standardized procedures are currently available only in English.
Patients that are currently using a CPAP appliance and are responding well to the treatment.
Design:
Participants will have 4 scheduled clinic visits over about 5 months. Participants will be screened. Tests will include an exam of the head, face, jaws, mouth and teeth. Participants will have a three dimensional (3D) low radiation x-ray of the head (CBCT), photos of their teeth and face, and digital 3D dental scan. Their parents or caregivers will answer questions about their sleep and breathing problems.
Participants will have one overnight sleep study at the NIH to confirm their OSA diagnosis, unless a sleep study was done recently. During the sleep study, sticky pads with sensors will be placed on their face and body, and small tubes will be placed in the nostrils while they sleep. A parent/caregiver will sleep in the same room.
The DynaFlex Dorsal Accu-fit will be custom-made for each participant. The device fits on the teeth and holds the lower jaw in a forward position, opening the airway during sleep.
There will be an initial adjustment period of 1 to 4 weeks during which the device is adjusted by the parents/caregivers at home in communication with the study team, and the participant gradually gets comfortable wearing the device during sleep. Parents will download an app to record snoring during this period.
After this period, the participants will wear their device every night for 4 months. They will have a clinic visit after the 1st month to make sure that everything is ok, and an end-of-study visit where all the initial tests are going to be repeated, including the sleep study.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Study Description:
This will be a single-arm, prospective, pilot clinical trial with the aim of determining the adherence rate, safety, and preliminary efficacy of a mandibular advancement appliance (MAA) used as the study intervention during sleep in the management of obstructive sleep apnea (OSA) in children and adolescents. The MAA is the only study intervention being evaluated during sleep and is not intended to be used simultaneously with continuous positive airway pressure (CPAP) therapy.
Objectives:
Primary Objective:
To assess the adherence, safety, and preliminary efficacy of the use of a mandibular advancement appliance in the improvement of the OSA symptoms in children.
Secondary Objectives:
- To assess the impact of the use of the appliance on craniofacial skeletal relationships
- Evaluate the potential impact of the use of the appliance in the morphology of the nasopharyngeal airway
- The assessment of the changes in the symptoms associated with OSA pre- and post-intervention
- The evaluation of the changes in the quality of life of the participants
Endpoints:
Primary Endpoints:
- The number of nights that the patient has been wearing the appliance per week
- The number and type of associated adverse events reported during the trial
- The change in the Apnea Hypopnea Index (AHI) pre- and post-study intervention
Secondary Endpoints:
- Detailed clinical and radiographic craniofacial evaluation of pre- and post-treatment dental and skeletal tissue relationships with the use of clinical records and CBCT scan images.
- Assessment of the changes in the airway volume and minimal axial sections areas with the use of a pre- and post-treatment CBCT scan
- The scores in the Pediatric Sleep Questionnaire (PSQ) pre- and post-intervention will be compared.
- The scores in the OSA-18 questionnaire pre- and post-intervention will be compared.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Konstantinia Almpani, D.D.S.
- Numero di telefono: (301) 827-1647
- Email: nadine.almpani@nih.gov
Backup dei contatti dello studio
- Nome: Pamela M Orzechowski, R.N.
- Numero di telefono: (301) 402-7373
- Email: pamela.orzechowski@nih.gov
Luoghi di studio
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20892
- National Institutes of Health Clinical Center
-
Contatto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Numero di telefono: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet ALL the following criteria:
- Ability of the parent/s or caregiver/s to understand and the willingness to sign a written informed consent document.
- Stated willingness by the participant to comply with all study procedures and availability for the duration of the study
- Male or female, 6-17 years of age
- In good general health as evidenced by medical history
- Polysomnography-confirmed mild to moderate obstructive sleep apnea (OSA), for whom participation is clinically appropriate. For the purposes of eligibility, mild OSA is defined as AHI 1-4 events/hour and moderate OSA is defined as AHI 5-9 events/hour. Participants with AHI <1 will be considered screen failures. Participants with severe OSA, defined as AHI >=10 events/hour, or with PSG/clinical findings indicating a need for urgent standard clinical treatment, will be excluded and referred back to their treating provider.
- Ability to use the study device and be willing to adhere to the study intervention regimen
- Having healthy dentition, or in good repair.
- Having a mobile phone device or tablet that is compatible with the application that will be used for the snoring assessment ('SnoreLab')
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria will be excluded from participation in this study:
- Patients receiving medication that could be affecting the tone of their nasopharyngeal soft tissue and/or breathing during sleep in a direct or indirect way.
- Patients with a diagnosis of severe OSA based on PSG study results, defined as oAHI >=10 events/hour.
- Patients with a syndromic condition and/or genetic abnormalities that affect the craniofacial area.
- Patients with neuromotor impairment and/or neuromuscular disorder.
- Patients with parents or caregivers that cannot understand and/or speak English will be excluded because this study requires care giver-directed at-home device titration, safety monitoring, weekly reporting, and completion of study questionnaires, and the study materials and standardized procedures are currently available only in English
- Patients missing multiple teeth in a way that could compromise the retention or stability of the appliance in the mouth.
- Patients with oral lesions or gingival inflammation
- Pregnancy as verified by urine pregnancy test at the screening visit or during the study
- Known allergic reactions to any of the materials used for the construction of the study device.
- Patients that are currently using a CPAP appliance and are responding well to the treatment.
- Patients who have been exposed to significant radiation doses during the year prior to screening or are planning to undergo medical procedures that include exposure to significant radiation dosages will be excluded from the study.
- Participants with severe OSA, defined for purposes of this study as AHI >=10 events/hour, or with other PSG or clinical findings that, in the judgement of the sleep physician or Principal Investigator, indicate a need for urgent standard clinical treatment, will be excluded and referred back to their treating provider for appropriate clinical management.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Device: DynaFlex Dorsal Accu-Fit
This study intervention involves the daily use of an intraoral mandibular advancement appliance during sleep for a period of 4 months. This device is being used investigationally in children and adolescents. |
The DynaFlex Dorsal Accu-Fit is an FDA-cleared mandibular advancement appliance for the treatment/management of mild to moderate obstructive sleep apnea (OSA) in adults (K103076). Device labeling and manufacturer instructions describe the DynaFlex Dorsal as a device used for snoring and obstructive sleep apnea and note features intended to support comfort and nightly use, including a two-piece construction that allows some lateral jaw movement and adjustable mandibular advancement. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The primary objective of this study is to determine the adherence levels, the safety, and the preliminary efficacy of this anterior mandibular repositioning appliance in the management of OSA in children.
Lasso di tempo: 5 months.
|
- The number of nights that the patient has been wearing the appliance per week.- Number and type of associated adverse events reported during the trial.- The pre- and post-intervention change in the Apnea Hypopnea Index (AHI) |
5 months.
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The evaluation of the potential impact of the use of the appliance on the morphology of the nasopharyngeal airway.
Lasso di tempo: 4 months.
|
Assessment of the changes in the airway volume and minimal axial sections areas with the use of a pre- and post-treatment CBCT scan. |
4 months.
|
|
The evaluation of the impact of the use of the appliance on craniofacial skeletal relationships.
Lasso di tempo: 4 months.
|
Detailed clinical and radiographic craniofacial evaluation of pre- and post-treatment dental and skeletal tissue relationships with the use of clinical records and CBCT scan images. |
4 months.
|
|
The potential changes in the symptoms associated with OSA pre- and post-intervention.
Lasso di tempo: 4 months.
|
The scores in the Pediatric Sleep Questionnaire (PSQ) pre- and post-intervention will be compared. |
4 months.
|
|
The changes in the quality of life of the participants.
Lasso di tempo: 4 months.
|
The scores in the OSA-18 questionnaire pre- and post-intervention will be compared. |
4 months.
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Konstantinia Almpani, D.D.S., National Institute of Dental and Craniofacial Research (NIDCR)
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Malattie stomatognatiche
- Malattie del sistema nervoso
- Disturbi della nutrizione
- Ipernutrizione
- Peso corporeo
- Malattie della mascella
- Malattie delle vie respiratorie
- Disturbi respiratori
- Disturbi del sonno e della veglia
- Anomalie della mascella
- Anomalie maxillo-facciali
- Anomalie craniofacciali
- Anomalie muscoloscheletriche
- Malattie mandibolari
- Anomalie del sistema stomatognatico
- Anomalie congenite
- Sovrappeso
- Apnea
- Disturbi del sonno, intrinseci
- Dissonnie
- Sindromi da apnee notturne
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Obesità
- Retrognazia
- Apnea notturna, ostruttiva
- Micrognatismo
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 10002503
- 002503-D
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Study complies with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
Periodo di condivisione IPD
At the time of publication or 3 years after the completion of the primary endpoint, whichever comes first.
Criteri di accesso alla condivisione IPD
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .