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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00477009
Other study ID # K2007-70X-20517-01-3
Secondary ID Dnr 07-032M
Status Completed
Phase N/A
First received May 21, 2007
Last updated January 17, 2013
Start date May 2007
Est. completion date December 2011

Study information

Verified date January 2013
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Sweden Depts of Respiratory Medicine and Orthodontics, Umeå University Umeå

Sponsors (2)

Lead Sponsor Collaborator
Umeå University The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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

Outcome

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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