A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Apnea Syndromes
- Sponsor
- Umeå University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Sleep apnea and sleep measured by polysomnography
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
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.
Investigators
Marie Marklund
Associate professor
Umeå University
Eligibility 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
Outcomes
Primary Outcomes
Sleep apnea and sleep measured by polysomnography
Time Frame: Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Time Frame: Baseline and after 4 months
Quality of life
Time Frame: Baseline and after 4 months
Secondary Outcomes
- Markers of inflammation(Baseline and after 4 months)
- Markers of cardiovascular health and oxidative stress(Baseline and after 4 months)
- Side-effects from the treatment(After 4 months treatment)
- Predictors of effects on symptoms and sleep apneas(After 4 months treatment)
- Headaches(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)