Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Apnea Syndromes Snoring Disorders of Excessive Somnolence |
Device: Mandibular repositioning appliance, adjustable |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring |
- Sleep apnea and sleep measured by polysomnography [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Headaches [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: Yes ]
- Vigilance [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Markers of stress [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Markers of inflammation [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Markers of cardiovascular health and oxidative stress [ Time Frame: Baseline and after 4 months ] [ Designated as safety issue: No ]
- Side-effects from the treatment [ Time Frame: After 4 months treatment ] [ Designated as safety issue: No ]
- Predictors of effects on symptoms and sleep apneas [ Time Frame: After 4 months treatment ] [ Designated as safety issue: No ]
| Enrollment: | 96 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Adjustable mandibular repositioning appliance
|
Device: Mandibular 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.
Other Name: Herbst appliance
|
|
Placebo Comparator: 2
Placebo device in upper jaw
|
Device: Mandibular 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.
Other Name: Herbst appliance
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Sweden | |
| Depts of Respiratory Medicine and Orthodontics, Umeå University | |
| Umeå, Sweden, SE-906 51 | |
| Principal Investigator: | Marie Marklund | Umeå University |
More Information
Publications:
| Responsible Party: | Marie Marklund, Associate professor, Umeå University |
| ClinicalTrials.gov Identifier: | NCT00477009 History of Changes |
| Other Study ID Numbers: | K2007-70X-20517-01-3, Dnr 07-032M |
| Study First Received: | May 21, 2007 |
| Last Updated: | January 17, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: The National Board of Health and Welfare |
Keywords provided by Umeå University:
|
Sleep apnea syndromes Snoring Mandibular advancement Activator appliances Disorders of excessive somnolence |
Blood pressure Inflammation Oxidative stress Hormones Markers of Metabolic Syndrome X |
Additional relevant MeSH terms:
|
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Disorders of Excessive Somnolence Snoring Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Respiratory Sounds |
ClinicalTrials.gov processed this record on June 17, 2013