Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 202
- Primary Endpoint
- Predictive Accuracy
Study Overview
Brief 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.
Detailed Description
I. BACKGROUND AND SIGNIFICANCE
Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs. Almost thirty years ago, initial population studies found the prevalence of OSA to be five to nine per cent of the adult population. Excess body weight is a risk factor for the development of OSA, and the recent rise in prevalence of obesity has led to revised estimates of OSA prevalence, now at seventeen per cent of the adult population. OSA is poorly recognized clinically; currently 85% of apneics remain undiagnosed and untreated.
OSA derives fundamentally from structural abnormalities of the pharynx that cause pharyngeal narrowing or closure during sleep and produce recurrent apneas and hypopneas. During wakefulness compensatory neuromuscular reflexes protect the pharynx from collapse. These reflexes are lost during sleep, leaving the collapsible human pharynx susceptible to narrowing or closure. Nasal continuous positive airway pressure (CPAP), comprised of an air generator and nose mask, is the standard therapy for OSA. CPAP delivers positive pressure to the pharyngeal lumen, thereby dilating it and eliminating obstruction. While this therapy is highly efficacious, it is cumbersome and its effectiveness is compromised by a relatively low adherence rate. Adherence depends on the methods used to initiate therapy and on the severity of OSA, being higher in subjects with more severe hypoxemia and excessive daytime sleepiness. In current practice, CPAP adherence rate appears to approximate fifty per cent.
The only currently available alternative to CPAP is oral appliance (OA) therapy. Oral appliances maintain patency of the airway during sleep by stabilizing and protruding the mandible and/or the tongue. The most commonly used type of OA is a custom-made mandibular repositioner (MR) which protrudes the mandible. Mandibular protrusion in paralyzed subjects dilates both the velopharynx and the oropharynx. In clinical practice, a specialist dentist fabricates a custom-fitted appliance covering upper and lower teeth. The appliance is then empirically adjusted to progressively protrude the mandible until a therapeutic end-point is reached. OA therapy is better accepted by the OSA subject than nasal CPAP, and self-reported adherence rates are high. Unfortunately, OA therapy is not uniformly effective in OSA. Reported effectiveness ranges from 50 to 70 percent, and our recent study found a 58% percent success rate. In short, two therapies are currently available for treating OSA, and each has its own shortcomings: 1) CPAP is efficacious but not uniformly tolerated by subjects; and 2) OAT is not highly efficacious but is better tolerated than CPAP.
II. CURRENT STATUS OF MEDICAL PRACTICE
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 21 and 80 yrs
- •Obstructive sleep apnea (AHI > 10hr-1)
- •Body mass index less than 40 kg/m2
- •Neck circumference less than 50 cm
- •Absence of severe oxyhemoglobin desaturation during sleep as indicated by a mean value of oxygen saturation (SaO2) greater than 90 percent
- •Mandibular range of motion greater than 5 mm
- •Adequate dentition (10 upper and 10 lower teeth)
- •Ability to understand and provide informed consent
- •Subjects will be recruited from the population of subjects seen by the PI or other sleep physicians at the out-patient clinic of the Foothills Medical Center Sleep Disorders Center (Calgary, Canada), and by the dental co-investigator at the Snore Centre (Calgary, Canada).
Exclusion Criteria
- •Inability to breathe comfortably through the nose
- •Central Sleep Apnea
- •Anticipated change in medical therapy that could alter the severity of OSA during the protocol
- •Anticipated change in body weight (5% or more) during the protocol
- •Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
- •Severe respiratory disorder(s) other than sleep disordered breathing
- •Loose teeth or advanced periodontal disease
Arms & Interventions
Computer Controlled Mandibular Positioner
All study participants will undergo the computer controlled mandibular positioner test.
Intervention: Computer controlled mandibular positioner (Device)
Outcomes
Primary Outcomes
Predictive Accuracy
Time Frame: 4 weeks
Following the CCMP test, individuals will undergo a home sleep test to determine if the prediction made by the device was accurate (i.e. therapeutic responder or non-responder to oral appliance therapy).
Secondary Outcomes
No secondary outcomes reported