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

A vizsgálat adatai

Ki végzi

National Institute of Dental and Craniofacial Research (NIDCR)

Azonosító

NCT07902908

A regiszteradat frissítve

2026. november 12.

Eredeti leírás

Background:A teljes eredeti leírásKevesebb

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.

Kizáró feltételek: 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.

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').

ClinicalTrials.gov NCT07902908