Clinical trial NCT00477009: Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
Official title: A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Snoring
Disorders of Excessive Somnolence
Keywords: Sleep apnea syndromes
Snoring
Mandibular advancement
Activator appliances
Disorders of excessive somnolence
Blood pressure
Inflammation
Oxidative stress
Hormones
Markers of Metabolic Syndrome X
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2007-05-22
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep apnea and sleep measured by polysomnography
timeFrame: Baseline and after 4 months
measure: Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
timeFrame: Baseline and after 4 months
measure: Quality of life
timeFrame: Baseline and after 4 months
Secondary outcomes:
measure: Headaches
timeFrame: Baseline and after 4 months
measure: Blood pressure
timeFrame: Baseline and after 4 months
measure: Vigilance
timeFrame: Baseline and after 4 months
measure: Markers of stress
timeFrame: Baseline and after 4 months
measure: Markers of inflammation
timeFrame: Baseline and after 4 months
measure: Markers of cardiovascular health and oxidative stress
timeFrame: Baseline and after 4 months
measure: Side-effects from the treatment
timeFrame: After 4 months treatment
measure: Predictors of effects on symptoms and sleep apneas
timeFrame: After 4 months treatment
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Depts of Respiratory Medicine and Orthodontics, Umeå University
Study officials:
affiliation: Umeå University
name: Marie Marklund
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1378/chest.125.4.1270.
citation: Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004435. doi: 10.1002/14651858.CD004435.pub3.
citation: Rietz H, Franklin KA, Carlberg B, Sahlin C, Marklund M. Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial. J Am Heart Assoc. 2018 Jun 21;7(13):e008642. doi: 10.1161/JAHA.118.008642.
citation: Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. 2015 Aug;175(8):1278-85. doi: 10.1001/jamainternmed.2015.2051.