Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring

Umeå University

Status

Completed

Conditions

Snoring

Disorders of Excessive Somnolence

Sleep Apnea Syndromes

Treatments

Device: Mandibular repositioning appliance, adjustable

Study type

Interventional

Funder types

Other

Identifiers

NCT00477009

Dnr 07-032M

K2007-70X-20517-01-3

Details and patient eligibility

About

The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.

Full description

Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.

Enrollment

96 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
Snoring with excessive daytime sleepiness, apnea-hypopnea index of <5
Body mass index of <35

Exclusion criteria

Unable to give informed consent
Psychiatric disorders including dementia that may interfere with the study protocol
Other concomitant diseases that demand acute, effective treatment of sleep apnea
Pharyngeal soft tissue abnormalities
Living to far away from the University Hospital
Professional drivers
Pregnancy
Included in other studies
Other sleep apnea treatments
Severe craniomandibular disorders
Acute or advanced periodontal disease
Insufficient number of teeth