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

January 17, 2013 updated by: Marie Marklund, Umeå University

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 Overview

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Umeå, Sweden, SE-906 51
        • Depts of Respiratory Medicine and Orthodontics, Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Adjustable mandibular repositioning appliance
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.
Other Names:
  • Herbst appliance
Placebo Comparator: 2
Placebo device in upper jaw
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.
Other Names:
  • Herbst appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep apnea and sleep measured by polysomnography
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Quality of life
Time Frame: Baseline and after 4 months
Baseline and after 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Headaches
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Blood pressure
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Vigilance
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Markers of stress
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Markers of inflammation
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Markers of cardiovascular health and oxidative stress
Time Frame: Baseline and after 4 months
Baseline and after 4 months
Side-effects from the treatment
Time Frame: After 4 months treatment
After 4 months treatment
Predictors of effects on symptoms and sleep apneas
Time Frame: After 4 months treatment
After 4 months treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie Marklund, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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