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Sponsors and Collaborators: |
Nykøbing Falster County Hospital University of Copenhagen Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark |
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Information provided by: | Nykøbing Falster County Hospital |
ClinicalTrials.gov Identifier: | NCT00243139 |
The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.
Condition | Intervention | Phase |
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Sleep Apnea Syndromes Sleep Apnea Obstructive Sleep Apnea |
Device: Mandibular advancement device (activator) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea |
Estimated Enrollment: | 90 |
Study Start Date: | July 1999 |
Estimated Study Completion Date: | February 2004 |
Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.
In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Storstrøms County | |
Nykoebing Falster County Hospital | |
Nykoebing Falster, Storstrøms County, Denmark, DK-4800 |
Principal Investigator: | Niels Petri, MD | Nykoebing Falster County Hospital |
Study ID Numbers: | SNB01 |
Study First Received: | October 20, 2005 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00243139 |
Health Authority: | Denmark: The Ministry of the Interior and Health |
Oral appliances Obstructive sleep apnea Epworth Sleepiness Scale SF-36 |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Pathologic Processes Disease Syndrome Nervous System Diseases |