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

NCT00477009 | Completed

• 2 other identifiers: K2007-70X-20517-01-3Dnr 07-032M
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

1

EXPERIMENTAL

Adjustable mandibular repositioning appliance

Device: Mandibular repositioning appliance, adjustable

2

PLACEBO COMPARATOR

Placebo device in upper jaw

Device: Mandibular repositioning appliance, adjustable

Interventions

Mandibular repositioning appliance, adjustable 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.

Also known as: Herbst appliance

1; 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Depts of Respiratory Medicine and Orthodontics, Umeå University

Umeå, SE-906 51, Sweden

Location

Related Publications (4)

• 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.

  PMID: 15078734 BACKGROUND

• 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.

  PMID: 16437488 BACKGROUND

• 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.

  PMID: 29929990 DERIVED

• 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.

  PMID: 26030264 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring; Disorders of Excessive Somnolence; Inflammation

Interventions

Orthodontic Appliances, Functional

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Marie Marklund

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

SE (1)