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Completed

NCT Number: NCT02148510

Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year.

This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Bruxism Dyssomnias Habits Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Västmanland County Hospitals, Västerås, Västmanland County, Sweden

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About this study

The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The diagnosis of obstructive sleep apnea with AHI > 15
  • Odontological status that allows retention of oral devices and with at least one molar in each quadrant
  • Maximal protrusion >6 mm
  • Subject giving his/her informed concent
  • Understands and can communicate in Swedish
  • Subject understands the instruction on how to put on the polygraphy equipment at home
  • Valid AHI data at baseline respiratory analysis

Exclusion criteria

  • age< 18 år
  • BMI >35
  • Jaw complaints requiring treatment the past year
  • Pain or locking of the jaw at the enrollment visit
  • At the discretion of the investigator judged not being able to attach to the study directives
  • Hypersensitive to the material of the devices
  • Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment

Treatment and study plan

Monobloc

Device

Construction fitted to upper and lower jaw

Other names: Mandibular protruding device

Bibloc

Device

Biblock construction

Other names: Narval

Primary outcomes

  1. Apnoea-Hypopnea-Index (AHI)

    Time frame: 9 weeks after start of study

    AHI defined by American Academy of Sleep Medicine (AASM)

Secondary outcomes

  1. Oxygen Desaturation Index (ODI)

    Time frame: 9 weeks

    Number of episodes per hour with arterial oxygen saturation decline of 3% or more

  2. Sleepiness

    Time frame: 9 weeks and 1 year

    Epworth Sleepiness Scale (ESS)

  3. Quality of life

    Time frame: 9 weeks and 1 year

    Functional Outcomes of Sleep Questionnaire (FOSQ )

  4. Sleep bruxism

    Time frame: 9 weeks

    Bruxism episodes during sleep

  5. Adverse events

    Time frame: 1 year

    Subject reported and objective investigator observed events

Other outcomes

  1. Cost of care

    Time frame: 1 year

    Total cost calculation including the device, repairs and adjustments and consumption of dentist time

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 28, 2014
Registry last updated
Nov 8, 2017

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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