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