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Sponsors and Collaborators: |
Umeå University Swedish Research Council |
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Information provided by: | Umeå University |
ClinicalTrials.gov Identifier: | NCT00477009 |
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.
Condition | Intervention |
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Sleep Apnea Syndromes Snoring Disorders of Excessive Somnolence |
Device: Mandibular repositioning appliance, adjustable |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring |
Estimated Enrollment: | 200 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Adjustable mandibular repositioning appliance
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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.
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2: Placebo Comparator
Placebo device in upper jaw
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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.
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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.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marie Marklund, PhD, DDS | +46706360729 | Marie.Marklund@odont.umu.se |
Contact: Karl A Franklin, PhD, MD | +46706884745 | Karl.Franklin@lung.umu.se |
Sweden | |
Depts of Respiratory Medicine and Orthodontics, Umeå University | Recruiting |
Umeå, Sweden, SE-906 51 | |
Contact: Marie Marklund, PhD, DDS +46706360729 Marie.Marklund@odont.umu.se | |
Contact: Karl A Franklin, PhD, MD +46706884745 Karl.Franklin@ung.umu.se | |
Principal Investigator: Marie Marklund, PhD, DDS | |
Sub-Investigator: Karl A Franklin, PhD, MD |
Principal Investigator: | Marie Marklund | Umeå University |
Responsible Party: | Umeå University ( Vice-Chancellor, Göran Sandberg ) |
Study ID Numbers: | K2007-70X-20517-01-3, Dnr 07-032M |
Study First Received: | May 21, 2007 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00477009 |
Health Authority: | Sweden: Regional Ethical Review Board; Sweden: The National Board of Health and Welfare |
Sleep apnea syndromes Snoring Mandibular advancement Activator appliances Disorders of excessive somnolence |
Blood pressure Inflammation Oxidative stress Hormones Markers of Metabolic Syndrome X |
Respiratory Sounds Sleep Apnea Syndromes Metabolic Syndrome X Apnea Sleep Apnea, Obstructive Respiration Disorders Snoring Dyssomnias Stress Sleep Disorders |
Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Inflammation Signs and Symptoms Respiratory Tract Diseases Mental Disorders Syndrome X Signs and Symptoms, Respiratory Abdominal obesity metabolic syndrome |
Pathologic Processes Disease Syndrome Nervous System Diseases |