Use of a Mandibular Advancement Appliance in Children With Obstructive Sleep Apnea

November 11, 2026 updated by: National Institute of Dental and Craniofacial Research (NIDCR)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. To assess the impact of the use of the appliance on craniofacial skeletal relationships
  2. Evaluate the potential impact of the use of the appliance in the morphology of the nasopharyngeal airway
  3. The assessment of the changes in the symptoms associated with OSA pre- and post-intervention
  4. The evaluation of the changes in the quality of life of the participants

Endpoints:

Primary Endpoints:

  1. The number of nights that the patient has been wearing the appliance per week
  2. The number and type of associated adverse events reported during the trial
  3. The change in the Apnea Hypopnea Index (AHI) pre- and post-study intervention

Secondary Endpoints:

  1. 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.
  2. Assessment of the changes in the airway volume and minimal axial sections areas with the use of a pre- and post-treatment CBCT scan
  3. The scores in the Pediatric Sleep Questionnaire (PSQ) pre- and post-intervention will be compared.
  4. The scores in the OSA-18 questionnaire pre- and post-intervention will be compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
        • Contact:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet ALL the following criteria:

  1. Ability of the parent/s or caregiver/s to understand and the willingness to sign a written informed consent document.
  2. Stated willingness by the participant to comply with all study procedures and availability for the duration of the study
  3. Male or female, 6-17 years of age
  4. In good general health as evidenced by medical history
  5. 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.
  6. Ability to use the study device and be willing to adhere to the study intervention regimen
  7. Having healthy dentition, or in good repair.
  8. 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:

  1. 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.
  2. Patients with a diagnosis of severe OSA based on PSG study results, defined as oAHI >=10 events/hour.
  3. Patients with a syndromic condition and/or genetic abnormalities that affect the craniofacial area.
  4. Patients with neuromotor impairment and/or neuromuscular disorder.
  5. 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
  6. Patients missing multiple teeth in a way that could compromise the retention or stability of the appliance in the mouth.
  7. Patients with oral lesions or gingival inflammation
  8. Pregnancy as verified by urine pregnancy test at the screening visit or during the study
  9. Known allergic reactions to any of the materials used for the construction of the study device.
  10. Patients that are currently using a CPAP appliance and are responding well to the treatment.
  11. 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.
  12. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: DynaFlex Dorsal Accu-Fit

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The evaluation of the potential impact of the use of the appliance on the morphology of the nasopharyngeal airway.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 4 months.

The scores in the OSA-18 questionnaire pre- and post-intervention will be compared.
4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Konstantinia Almpani, D.D.S., National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 5, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10002503
  • 002503-D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

At the time of publication or 3 years after the completion of the primary endpoint, whichever comes first.

IPD Sharing Access Criteria

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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