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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Monobloc
* Device: Bibloc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monobloc<br>Treatment with an appliance that holds the lower jaw in a fixed protruded position | Device: Monobloc<br>* Construction fitted to upper and lower jaw<br>* Other names: Mandibular protruding device;|
| Active Comparator: Bibloc<br>Bibloc device where a maxillary splint is connected to a mandibular splint by a connector allowing a slight opening of the jaw without compromizing the protrusion (Narval) | Device: Bibloc<br>* Biblock construction<br>* Other names: Narval;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnoea-Hypopnea-Index (AHI) | AHI defined by American Academy of Sleep Medicine (AASM) | 9 weeks after start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Desaturation Index (ODI) | Number of episodes per hour with arterial oxygen saturation decline of 3% or more | 9 weeks | 
| Sleepiness | Epworth Sleepiness Scale (ESS) | 9 weeks and 1 year | 
| Quality of life | Functional Outcomes of Sleep Questionnaire (FOSQ ) | 9 weeks and 1 year | 
| Sleep bruxism | Bruxism episodes during sleep | 9 weeks | 
| Adverse events | Subject reported and objective investigator observed events | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism, cost