Disorders of Excessive Somnolence, Sleep Apnea Syndromes, Snoring
Conditions
Keywords
Sleep apnea syndromes, Snoring, Mandibular advancement, Activator appliances, Disorders of excessive somnolence, Blood pressure, Inflammation, Oxidative stress, Hormones, Markers of Metabolic Syndrome X
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.
Interventions
DEVICEMandibular repositioning appliance, adjustable
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.
Sponsors
The Swedish Research Council
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Markers of stress | Baseline and after 4 months |
| Markers of inflammation | Baseline and after 4 months |
| Headaches | 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 |
| Markers of cardiovascular health and oxidative stress | Baseline and after 4 months |
| Blood pressure | Baseline and after 4 months |
| Vigilance | Baseline and after 4 months |
Countries
Sweden
Outcome results
None listed