Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring - Full Text View

Sponsor:	Umeå University
Collaborator:	The Swedish Research Council
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00477009

Purpose

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
Sleep Apnea Syndromes Snoring Disorders of Excessive Somnolence	Device: Mandibular repositioning appliance, adjustable

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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:

Sleep apnea and sleep measured by polysomnography [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Headaches [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: Yes ]
Vigilance [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Markers of stress [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Markers of inflammation [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Markers of cardiovascular health and oxidative stress [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
Side-effects from the treatment [ Time Frame: After 4 months treatment ] [ Designated as safety issue: No ]
Predictors of effects on symptoms and sleep apneas [ Time Frame: After 4 months treatment ] [ Designated as safety issue: No ]

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

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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477009

Contacts

Contact: Marie Marklund, PhD, DDS	+46706360729	Marie.Marklund@odont.umu.se
Contact: Karl A Franklin, PhD, MD	+46706884745	Karl.Franklin@lung.umu.se

Locations

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

Sponsors and Collaborators

Umeå University

The Swedish Research Council

Investigators

Principal Investigator:

Marie Marklund

Umeå University

More Information

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.

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

Responsible Party:	Vice-Chancellor, Göran Sandberg, Umeå University
ClinicalTrials.gov Identifier:	NCT00477009 History of Changes
Other Study ID Numbers:	K2007-70X-20517-01-3, Dnr 07-032M
Study First Received:	May 21, 2007
Last Updated:	June 30, 2008
Health Authority:	Sweden: Regional Ethical Review Board; Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:

Sleep apnea syndromes
Snoring
Mandibular advancement
Activator appliances
Disorders of excessive somnolence

Blood pressure
Inflammation
Oxidative stress
Hormones
Markers of Metabolic Syndrome X

Additional relevant MeSH terms:

Apnea
Disorders of Excessive Somnolence
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Respiratory Sounds

ClinicalTrials.gov processed this record on February 09, 2012