Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance



Status:Withdrawn
Conditions:Insomnia Sleep Studies, Dental, Pulmonary
Therapuetic Areas:Dental / Maxillofacial Surgery, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:2/7/2019
Start Date:April 1, 2018
End Date:January 2, 2019

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A prospective study measuring changes in upper airway anatomy, quality of life measures, and
polysomnographic parameters using a functional dental appliance (Homeoblock)

Although rising levels of obesity heavily influences the increasing rates of obstructive
sleep apnea (OSA), detailed analysis of more basic etiology suggests a possible craniofacial
origin. Specifically, modern humans' facial structures a slowly shrinking, which can narrow
the upper airway. This is evidenced by the fact that rates of malocclusion and impacted (or
non-existent) wisdom teeth are increasing in modern, Westernized countries.

Obstructive sleep apnea is a commonly seen condition characterized by multiple episodes of
obstructed breathing during sleep, with intermittent hypoxia. Untreated OSA is associated
with significantly higher rates of high blood pressure, diabetes, heart disease, heart
attack, stroke, sudden death, and car accidents. The gold standard treatment for OSA is
continuous positive airway pressure (CPAP), but compliance is poor. Initially, out of 100
patients, 20 will refuse CPAP. After one year 50% of the 80 remaining patients will be using
CPAP, but only 50% will be using it effectively, leaving only 20 patients who are using CPAP
effectively. (personal communication, Stepnowski).

An alternative option in people with mild to moderate OSA is a mandibular advancement device,
which functions by pulling the genioglossus muscle forward. Long-term use of CPAP and
mandibular advancement devices have been shown to aggravate malocclusion. Numerous surgical
options are available for select patients, but only as a last resort.

In children, one uncommonly used, but effective form of treating OSA is by application of a
palatal expander by an orthodontist. In theory, this option is effective due to the fact the
palatal suture line is not completely fused in children. The general consensus in dentistry
is that adults have fused midline palatal suture line and the hard palate cannot be expanded.

Recent work by numerous investigators suggests that palatal expansion can occur to
significant degrees, even in adults. Case reports have been published with the AHI
diminishing significantly after therapy. Not only can the hard palate widen, there can also
be significant growth of new maxillary bone growth and anterior mandibular bone growth. Jaw
development is linked to airway development.

The Homeoblock is once such appliance that is based on principles of epigenetics. Mechanical
stimulation by the device is thought to initiate gene transcription within the periodontal
ligament, creating dental movement and new bone formation.

Our study aims to determine the efficacy of the Homeoblock in patients with obstructive sleep
apnea with regards to changes in polysomnographic parameters, functional quality of life
measures, and upper airway anatomy size using low-dose CT imaging.

Inclusion Criteria:

- Documented AHI > 15 on polysomnography

- Refuses CPAP

- Able to fill our QOL and sleep questionnaires (pre and one year post treatment)

- Willing to undergo CBCT radiologic testing x 2 (pre and 1 year post treatment)

Exclusion Criteria:

- neurologic conditions

- dementia

- central sleep apnea

- heart failure, seizures

- age < 18

- severe nasal congestion

- insufficient teeth

- lack of manual dexterity
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 929-263-3130
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
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