Sleep Apnea Syndromes Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Depts of Respiratory Medicine and Orthodontics, Umeå University | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | The Swedish Research Council |
Sweden,
Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004435. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep apnea and sleep measured by polysomnography | Baseline and after 4 months | No | |
Primary | Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing | Baseline and after 4 months | No | |
Primary | Quality of life | Baseline and after 4 months | No | |
Secondary | Headaches | Baseline and after 4 months | No | |
Secondary | Blood pressure | Baseline and after 4 months | Yes | |
Secondary | Vigilance | Baseline and after 4 months | No | |
Secondary | Markers of stress | Baseline and after 4 months | No | |
Secondary | Markers of inflammation | Baseline and after 4 months | No | |
Secondary | Markers of cardiovascular health and oxidative stress | Baseline and after 4 months | No | |
Secondary | Side-effects from the treatment | After 4 months treatment | No | |
Secondary | Predictors of effects on symptoms and sleep apneas | After 4 months treatment | No |
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