Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Snoring; Disorders of Excessive Somnolence
• Interventions: Device: Mandibular repositioning appliance, adjustable

• Registration Number: NCT00477009
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mandibular repositioning appliance, adjustable	Adjustable mandibular repositioning appliance
2	Mandibular repositioning appliance, adjustable	Placebo device in upper jaw

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Depts of Respiratory Medicine and Orthodontics, Umeå University; 🇸🇪 Umeå, Sweden