A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring
Sponsor study identifier
Secondary identifiers
interventional
96
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 21, 2007
Actual (reported)May 22, 2007
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Sleep apnea and sleep measured by polysomnography
Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Baseline and after 4 months
Quality of life
Baseline and after 4 months
Headaches
Adjustable mandibular repositioning appliance
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Depts of Respiratory Medicine and Orthodontics, Umeå University
Umeå, SE-906 51, Sweden
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.
Marie Marklund
Umeå University
96 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2007
First Posted
May 22, 2007
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Caffeine Reduction on Snoring and Quality of Life
Baseline and after 4 months
Blood pressure
Baseline and after 4 months
Vigilance
Baseline and after 4 months
Markers of stress
Baseline and after 4 months
Markers of inflammation
Baseline and after 4 months
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 18, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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