Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy

Summary

Sleep apnea is a condition in which the throat air passage closes during sleep and repeatedly interrupts breathing. The standard treatment of sleep apnea is air pressure applied to the nose, so-called nasal CPAP, but it is not suitable for all patients. Another treatment is to use a dental appliance while asleep. In this treatment, an appliance covers the upper and lower teeth and acts to pull the jaw forward, which opens the throat passage. This allows the patient to breathe normally.

Dental appliance treatment does not work effectively in all patients. In order to identify those in whom dental appliance therapy will be effective, the study sponsor has invented the remotely controlled mandibular positioner, MATRx. The MATRx is an FDA cleared motorized dental appliance which is used overnight in hospital sleep studies and works by pulling the jaw outward under the control of a technician.

In order to eliminate the need for an overnight in hospital sleep study, the sponsor has invented a new device that allows for the identification of individuals who are suitable candidates for dental appliance therapy from the comfort of the home. Like with MATRx, participants will sleep with a motorized mandibular positioner in place. But, it is controlled by a computer, rather than a sleep technician, making it a computer controlled mandibular positioner (CCMP). The feasibility and predictive accuracy of multi night testing using the CCMP will be evaluated through participation in this study.

The sponsor has carried out two previous research trials leading to the development of the CCMP. The first established the predictive accuracy of the remotely controlled mandibular positioner at identifying candidates suitable for oral appliance therapy and their effective therapeutic setting. The second established the accuracy of the algorithms used by the CCMP to similarly identify successful candidates in a clinical setting. No significant problems were identified in conjunction with our previous research protocol, and no significant risks were identified. This third protocol is to establish the feasibility and accuracy of the CCMP when used in the home setting.

The trial will utilize data collected over a series of nights to formulate a prediction of therapeutic outcome with an oral appliance. The prediction will be tested by comparing the degree of airway obstruction without treatment (from data collected prior to the study) to the degree of airway obstruction with oral appliance therapy. A custom fit oral appliance will be provided to participants as part of the trial.

The purpose of the study is to test the predictive accuracy of the CCMP in identifying favorable candidates for oral appliance therapy and in determining an efficacious protrusive position. Another purpose is to evaluate the convenience and possibility of carrying out a multi-night CCMP study in the home.

There are no known risks or side effects to the CCMP studies, to the home studies, or to the oral appliance therapy. It is possible that participants will have some discomfort during the nights of the CCMP studies but this will be transient and not cause any long term damage. Participants may experience soreness of the teeth or jaw joint during adjustment of the oral appliance by the dentist. There is no risk of jaw dislocation or problems with the temporomandibular joint (TMJ).

Participants will have the benefit of receiving a dental appliance for treating their sleep apnea at no charge. This will be supplied to participants by a dentist who is an expert in this field. Participation in the study will also allow the further development and ultimately commercialization of the CCMP device which may help individuals who have sleep apnea.

Dental appliance therapy is just one of two therapies for sleep apnea. If participants choose not to have the dental appliance therapy, they may wish to try nasal continuous positive airway pressure. Participants may withdraw at any time during the study without compromising their health care in any way. To withdraw, participants should simply notify one of the physicians or the research assistant. If the sponsor obtains new information that might affect an individual's willingness to participate in the study, they will be informed immediately.

Conditions

• Sleep Apnea, Obstructive

Interventions

DEVICE

Computer controlled mandibular positioner

Participants in this arm will complete the computer controlled mandibular positioner test. The study participant, study dentist, and PI are all blinded to the outcome of the CCMP test. Those participants predicted to experience therapeutic success with OAT will have their oral appliance set at the predicted protrusive level; those participants predicted to experience therapeutic failure will have their oral appliance set at a default position. Outcome home sleep tests with the oral appliance in place will be used to determine the accuracy of the prediction.

Sponsors & Collaborators

• Zephyr Sleep Technologies

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2016-10-31

Completion

2016-10-31