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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Umeå University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Umeå University

Dates:
Date Received: May 21, 2007
Date Started: May 2007
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013