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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Konstantinia Almpani, D.D.S.
- Número de teléfono: (301) 827-1647
- Correo electrónico: nadine.almpani@nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Pamela M Orzechowski, R.N.
- Número de teléfono: (301) 402-7373
- Correo electrónico: pamela.orzechowski@nih.gov
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
-
Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The evaluation of the potential impact of the use of the appliance on the morphology of the nasopharyngeal airway.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 4 months.
|
The scores in the OSA-18 questionnaire pre- and post-intervention will be compared. |
4 months.
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Konstantinia Almpani, D.D.S., National Institute of Dental and Craniofacial Research (NIDCR)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades del Sistema Nervioso
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Enfermedades de la mandíbula
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Trastornos del sueño y la vigilia
- Anomalías de la mandíbula
- Anomalías maxilofaciales
- Anomalías craneofaciales
- Anomalías musculoesqueléticas
- Enfermedades mandibulares
- Anomalías del sistema estomatognático
- Anomalías congénitas
- Exceso de peso
- Apnea
- Trastornos del Sueño Intrínsecos
- Disomnias
- Síndromes de apnea del sueño
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Retrognatia
- Apnea del Sueño Obstructiva
- Micrognatismo
Otros números de identificación del estudio
Otros números de identificación del estudio
- 10002503
- 002503-D
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
At the time of publication or 3 years after the completion of the primary endpoint, whichever comes first.
Criterios de acceso compartido de 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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