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

Brief Summary

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

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2011

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Adjustable mandibular repositioning appliance
  • Placebo Comparator: 2
    • Placebo device in upper jaw

Outcome Measures for this Clinical Trial

Primary Measures

  • Sleep apnea and sleep measured by polysomnography
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Quality of life
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No

Secondary Measures

  • Headaches
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Blood pressure
    • Time Frame: Baseline and after 4 months
      Safety Issue?: Yes
  • Vigilance
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Markers of stress
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Markers of inflammation
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Markers of cardiovascular health and oxidative stress
    • Time Frame: Baseline and after 4 months
      Safety Issue?: No
  • Side-effects from the treatment
    • Time Frame: After 4 months treatment
      Safety Issue?: No
  • Predictors of effects on symptoms and sleep apneas
    • Time Frame: After 4 months treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Umeå University
  • Collaborator
    • The Swedish Research Council
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marie Marklund, Associate professor – Umeå University
  • Overall Official(s)
    • Marie Marklund, Principal Investigator, Umeå University

References

Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004 Apr;125(4):1270-8.

Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004435. Review.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00477009