The Department of Otorhinolaryngology and Division of Prosthodontics of Montefiore Medical Center are enrolling patients with moderate to severe obstructive sleep apnea who can’t use CPAP. This is an innovative mouthguard (Homeoblock) that slowly enlarges your mouth and your airway.
To be eligible, the following are required:
- Adult, male or female, ages 18 to 65
- BMI (body mass index) < 35
- Documented moderate or severe obstructive sleep apnea on formal (home or in-lab sleep study), with an AHI > 1
- No significant nasal congestion
- Has tried an refuses CPAP.
- Has most teeth in good condition
- Willing to follow up for routine monthly visits for adjustments for one year.
If you have any of the following, you are NOT eligible:
- Neurologic conditions
- Central sleep apnea
- Heart failure
- Severe nasal congestion
- Lack of most teeth
An alternative to CPAP is a mandibular advancement device, where a custom-made mouth guard is used to pull the lower jaw forward, pulling the tongue away from the back of the throat. Our device is very difference from these mandibular advancement devices, in that it stimulates your teeth and jaws to grow slowly, expanding your dental arches and potentially increasing airway volume.
After a brief phone discussion, a 15 minute evaluation in person will be required with Dr. Park, to make sure you’re an appropriate candidate for the study. Informed consent will be obtained at this time. If enrolled, you will be required to follow-up on a monthly basis for adjustments for this one year study. A cone beam CAT scan will be performed at enrollment, and just after the 1 year study period. Various questionnaire will also be needed to be filled out at enrollment and at the end of the study. There is no compensation for the study.
Prior limited studies using similar technology have resulted in up to 59% increase in airway volume, and a 64% drop in the severity of sleep apnea (using the AHI). This study hopes to replicate and confirm these findings, but on a more formal basis for obstructive sleep apnea.
The Homeoblock is to be worn only at night. Potential risks are small, but side effects include:
- Bite changes that are usually temporary.
- Irritation to the gums.
- Increased radiation with the Cone Beam CT (about 10% of typical sinus CT dose of radiation)
If you meet all the above requirements and are interested in participating in this study, please contact Dr. Steven Y. Park at email@example.com.
G. Dave Singh; Tara Griffin; Samuel E Cress Biomimetic Oral Appliance Therapy in Adults with Severe Obstructive Sleep Apnea Sleep Disorder & Therapy Volume 5 Issue 1 (2016)