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

Sleep Apnea Syndromes Clinical Trial

Official title:

A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring

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

• Apnea
• Disorders of Excessive Somnolence
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

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