An interventional study of Mandibular repositioning appliance, adjustable in Sleep Apnea Syndromes, Snoring and Disorders of Excessive Somnolence, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-18.
Sponsored by Umeå University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 96 is above the median of 50 across 965 interventional studies indexed under Apnea.
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Exclusion Criteria:
Adjustable mandibular repositioning appliance
Device: Mandibular repositioning appliance, adjustable
Placebo device in upper jaw
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.
Also known as: Herbst appliance
Sleep apnea and sleep measured by polysomnography
Time frame: Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Time frame: Baseline and after 4 months
Quality of life
Time frame: Baseline and after 4 months
Headaches
Time frame: Baseline and after 4 months
Blood pressure
Time frame: Baseline and after 4 months
Vigilance
Time frame: Baseline and after 4 months
Markers of stress
Time frame: Baseline and after 4 months
Markers of inflammation
Time frame: Baseline and after 4 months
Markers of cardiovascular health and oxidative stress
Time frame: Baseline and after 4 months
Side-effects from the treatment
Time frame: After 4 months treatment
Predictors of effects on symptoms and sleep apneas
Time frame: After 4 months treatment
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Umeå University