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

NCT ID: NCT00477009

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Sleep Apnea Syndromes; Snoring; Disorders of Excessive Somnolence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Adjustable mandibular repositioning appliance

Group Type: EXPERIMENTAL

Mandibular repositioning appliance, adjustable

Intervention Type: DEVICE

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.

2

Placebo device in upper jaw

Group Type: PLACEBO_COMPARATOR

Mandibular repositioning appliance, adjustable

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Herbst appliance

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Marie Marklund

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Marklund

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Depts of Respiratory Medicine and Orthodontics, Umeå University

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 15078734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16437488 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29929990 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26030264 (View on PubMed)

Other Identifiers

Dnr 07-032M

Identifier Type: -

Identifier Source: secondary_id

K2007-70X-20517-01-3

Identifier Type: -

Identifier Source: org_study_id