- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00477009
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
Status
Completed
Intervention / Treatment
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
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Umeå, Sweden, SE-906 51
- Depts of Respiratory Medicine and Orthodontics, Umeå University
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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:
|
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:
|
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
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After 4 months treatment
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Predictors of effects on symptoms and sleep apneas
Time Frame: After 4 months treatment
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After 4 months treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
General Publications
- 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. doi: 10.1378/chest.125.4.1270.
- Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004435. doi: 10.1002/14651858.CD004435.pub3.
- Rietz H, Franklin KA, Carlberg B, Sahlin C, Marklund M. Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial. J Am Heart Assoc. 2018 Jun 21;7(13):e008642. doi: 10.1161/JAHA.118.008642.
- Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. 2015 Aug;175(8):1278-85. doi: 10.1001/jamainternmed.2015.2051.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Respiratory Sounds
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Apnea
- Snoring
- Disorders of Excessive Somnolence
- Sleepiness
Other Study ID Numbers
- K2007-70X-20517-01-3
- Dnr 07-032M
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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