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Completed

NCT Number: NCT00477009

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

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Disorders of Excessive Somnolence Dyssomnias Inflammation Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Depts of Respiratory Medicine and Orthodontics, Umeå University

Umeå, SE-906 51, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Herbst appliance

Primary outcomes

  1. Sleep apnea and sleep measured by polysomnography

    Time frame: Baseline and after 4 months

  2. Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing

    Time frame: Baseline and after 4 months

  3. Quality of life

    Time frame: Baseline and after 4 months

Secondary outcomes

  1. Headaches

    Time frame: Baseline and after 4 months

  2. Blood pressure

    Time frame: Baseline and after 4 months

  3. Vigilance

    Time frame: Baseline and after 4 months

  4. Markers of stress

    Time frame: Baseline and after 4 months

  5. Markers of inflammation

    Time frame: Baseline and after 4 months

  6. Markers of cardiovascular health and oxidative stress

    Time frame: Baseline and after 4 months

  7. Side-effects from the treatment

    Time frame: After 4 months treatment

  8. Predictors of effects on symptoms and sleep apneas

    Time frame: After 4 months treatment

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 22, 2007
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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