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Dental Device for Treatment of Sleep Apnea

2014-07-23 21:11:55 | BioPortfolio

Summary

This study is being done to see if treatment of obstructive sleep apnea (OSA) with a mandibular advancement device (MAD) shows an increase in the quality of life. Many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. The investigators will also see how helpful the mandibular advancement device is on insulin resistance.

Description

Patients with obstructive sleep apnea (OSA) will be included in this prospective controlled trial. OSA patients who are unable to tolerate CPAP or refuse CPAP and who are deemed appropriate by their attending physician for dental device treatment of OSA will be randomized to a control group (no MAD treatment) or to active MAD therapy.

Epidemiologic studies suggest that OSA is associated with insulin resistance independent of other known risk factors such as obesity. The cyclic intermittent hypoxia in OSA is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. There is an association between the level of hypoxic stress in OSA and insulin resistance.

The overall hypothesis to be tested is that treatment of OSA with MAD will improve insulin sensitivity, increase levels of HMW adiponectin, and improve psychological adjustment.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sleep Apnea Syndromes

Intervention

Mandibular advancement device, No mandibular advancement device

Location

The Ohio State University
Columbus
Ohio
United States
43210

Status

Recruiting

Source

Ohio State University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:55-0400

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PubMed Articles [4188 Associated PubMed Articles listed on BioPortfolio]

Biomechanical effect of mandibular advancement device with different protrusion positions for treatment of obstructive sleep apnea on tooth and facial bone: A finite element study.

The mandibular advancement device (MAD) is widely used for obstructive sleep apnea (OSA) treatment, and several studies have demonstrated its effectiveness. However, no comprehensive studies have yet ...

Neutral supporting mandibular advancement device with tongue bead for passive myofunctional therapy: a long term follow-up study.

Myofunctional therapy has been reported to be a valid adjunct treatment to OSA, but compliance was mentioned as an issue. We performed a prospective study on age matched randomized children submitted ...

Effect of oral appliance on circulating leukocyte telomere length and SIRT1 in obstructive sleep apnea.

The increased cardiovascular risk seen in patients with obstructive sleep apnea (OSA) may be due to combination of oxidative stress, systemic inflammation and damage to leukocyte telomere length (LTL)...

Difficult-to-treat OSAS: Combined continuous positive airway pressure (CPAP) and mandibular advancement devices (MADs) therapy. A case report.

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Mandibular Advancement Means Lower Facial Enlargement: A 2-Dimensional and 3-Dimensional Analysis.

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Medical and Biotech [MESH] Definitions

Moving a retruded mandible forward to a normal position. It is commonly performed for malocclusion and retrognathia. (From Jablonski's Dictionary of Dentistry, 1992)

A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)

Disorders characterized by multiple cessations of respirations during sleep that induce partial arousals and interfere with the maintenance of sleep. Sleep apnea syndromes are divided into central (see SLEEP APNEA, CENTRAL), obstructive (see SLEEP APNEA, OBSTRUCTIVE), and mixed central-obstructive types.

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Bone lengthening by gradual mechanical distraction. An external fixation device produces the distraction across the bone plate. The technique was originally applied to long bones but in recent years the method has been adapted for use with mandibular implants in maxillofacial surgery.

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