An interventional study of DynaFlex Dorsal Accu-Fit in Obstructive Sleep Apnea (OSA), Pediatric Obstructive Sleep Apnea (OSA) and Adeno-Tonsillar Hypertrophy, sponsored by National Institute of Dental and Craniofacial Research (NIDCR). Not yet recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Institute of Dental and Craniofacial Research (NIDCR) · Not applicable, Interventional, and Other
Among 753 studies in Sleep Apnea, Obstructive with a site in United States — 126 open to participants now, 160 under way, 9 of them phase 3. Sleep Apnea, Obstructive · United States.
Among the 753 studies in Sleep Apnea, Obstructive with a site in United States, this one is the 416th largest by planned enrollment of the 594 interventional ones that give a count, is one of 41 that started in 2026, is one of 410 with no phase, reaches primary completion later than 144 of the 159 other live ones, and was the 753rd registered.
2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.
Browse Sleep Apnea, Obstructive studies →126 of the 753 studies in Sleep Apnea, Obstructive with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+
Nevada Dental Sleep · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18–40 · Women only
Fisher and Paykel Healthcare · Sites in United States
Ages 22+
Brigham and Women's Hospital · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
753 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 85 · Phase 3 45 · Phase 4 36
First in 1999; this study’s year is marked. 41 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 49 across the 594 interventional studies, 81 across the 157 observational. Of the 512 that completed or were terminated, 257 (50%) have results posted.
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192 of 753 have an industry lead sponsor. The 10 most frequent:
This study is registered under National Institute of Dental and Craniofacial Research (NIDCR), one of the names counted as National Institutes of Health. Under that name alone:
National Institute of Dental and Craniofacial Research (NIDCR) is the lead sponsor of 95 studies on the registry; 10 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
National Institutes of Health has 5 studies filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
65 of the studies in Sleep Apnea, Obstructive with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT04814420Tulane UniversityAtrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study | 2026-11 |
| NCT07103941Isabel Moreno HayIOA Preventing Occlusal Changes With MAD Use | 2026-11-28 |
| NCT01857427Ulysses Magalang MDA Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities | 2026-12 |
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Among the 753 studies in Sleep Apnea, Obstructive with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 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:
Endpoints:
Primary Endpoints:
Secondary Endpoints:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this study, an individual must meet ALL the following criteria:
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
\- 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)
Time frame: 5 months.
The evaluation of the potential impact of the use of the appliance on the morphology of the nasopharyngeal airway.
Assessment of the changes in the airway volume and minimal axial sections areas with the use of a pre- and post-treatment CBCT scan.
Time frame: 4 months.
The evaluation of the impact of the use of the appliance on craniofacial skeletal relationships.
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.
Time frame: 4 months.
The potential changes in the symptoms associated with OSA pre- and post-intervention.
The scores in the Pediatric Sleep Questionnaire (PSQ) pre- and post-intervention will be compared.
Time frame: 4 months.
The changes in the quality of life of the participants.
The scores in the OSA-18 questionnaire pre- and post-intervention will be compared.
Time frame: 4 months.
Plan to share: Yes — 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.
Time frame: At the time of publication or 3 years after the completion of the primary endpoint, whichever comes first.
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.
Start is estimated for Nov 2026; primary completion for Jan 2029, 25 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 25 months is below that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Dental and Craniofacial Research (NIDCR) →