NCT00477009

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

A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Sleep Apnea Syndromes
• Snoring
• Disorders of Excessive Somnolence

Interventions

Type	Name	Description
DEVICE	Mandibular repositioning appliance, adjustable	Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-05-22
• Last updated: 2013-01-18

Locations

1 site across 1 country: Sweden