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Mouth device for children with obstructive sleep apnea

Tests a custom mouth device worn at night by children with sleep apnea.

Key facts

Who runs it: National Institute of Dental and Craniofacial Research (NIDCR)
Where: Bethesda, United StatesSee the site
Trial code: NCT07902908
Registry title: Use of a Mandibular Advancement Appliance in Children With Obstructive Sleep Apnea
Status: Not yet recruiting
People taking part: 25 people, planned
Starts: 18 Nov 2026
Expected to end: 1 Jan 2030
Type of study: Interventional
Treatments tested: DynaFlex Dorsal Accu-Fit
Record updated: 13 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 6 to 17 with mild to moderate obstructive sleep apnea. In this condition the airway gets blocked during sleep. They will wear a mouth device (DynaFlex Dorsal Accu-Fit) every night.

Age: 6 to 17 years
Sex: All sexes
Disease stage: Mild to moderate obstructive sleep apnea, confirmed by a sleep study. Mild is AHI 1-4 events/hour and moderate is AHI 5-9 events/hour. Children must be in good general health otherwise.
Earlier treatment: Children who now use a CPAP machine and are doing well with it cannot join.
Biomarker or test result: Sleep study (polysomnography) result: AHI 1-9 events/hour. AHI is the number of breathing pauses per hour of sleep.

Main reasons for not taking part

Severe sleep apnea (AHI 10 events/hour or more) or a need for urgent standard treatment
A syndrome or genetic condition affecting the face and skull, or a nerve or muscle disorder
Medicines that affect breathing or throat tissue during sleep
Many missing teeth, mouth sores or gum inflammation, or allergy to the device materials
Parents or caregivers who cannot understand or speak English, or pregnancy

The registry criteria, word for word

Show all 22 criteriaShow less

Who cannot take part

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 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
Patients with a syndromic condition and/or genetic abnormalities that affect the craniofacial area
Patients with neuromotor impairment and/or neuromuscular disorder
Known allergic reactions to any of the materials used for the construction of the study device
Individuals who meet any of the following criteria will be excluded from participation in this study:
Patients with a diagnosis of severe OSA based on PSG study results, defined as oAHI >=10 events/hour
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
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

Other criteria

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')

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 17 years old?

Where in United States

National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Not yet recruiting

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

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.

The group in the trial

Device: DynaFlex Dorsal Accu-FitTreatment being tested
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.
Treatment: DynaFlex Dorsal Accu-Fit