Clinical Trials Logo

Clinical Trial Summary

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.


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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00477009
Study type Interventional
Source Umeå University
Contact
Status Completed
Phase N/A
Start date May 2007
Completion date December 2011

See also
  Status Clinical Trial Phase
Recruiting NCT05477719 - Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment N/A
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A
Terminated NCT02735694 - Cycloserine in the Treatment of Sleep Apnea Phase 1
Active, not recruiting NCT02470182 - Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Completed NCT01457014 - Sleep Disordered Breathing and Chronic Pain N/A
Completed NCT00976417 - Mechanisms of Action of Adaptive Servoventilation N/A
Completed NCT00860743 - Respiratory and Autonomic Plasticity Following Intermittent Hypoxia Early Phase 1
Active, not recruiting NCT00371293 - The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Completed NCT00083798 - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland N/A
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A
Completed NCT00070681 - Outcomes of Sleep Disorders in Older Men Phase 3
Completed NCT00051363 - Apnea Positive Pressure Long-Term Efficacy Study Phase 3
Completed NCT00046670 - Sleep Disordered Breathing, APOE, and Lipid Metabolism N/A
Completed NCT00031239 - Sleep Apnea in Look AHEAD Participants - Ancillary to Look AHEAD N/A
Completed NCT00006323 - Neurobehavioral Consequences of Sleep Apnea in Children N/A
Terminated NCT00006321 - Neurocognitive Function in Snoring Children N/A
Completed NCT00005511 - SCOR in Neurobiology of Sleep--Intermediate Traits for Sleep Apnea N/A
Completed NCT00005275 - Sleep Heart Health Study (SHHS) Data Coordinating Center N/A