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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Monobloc; Device: Bibloc

• Registration Number: NCT02148510
• Lead Sponsor: Uppsala University

Brief Summary

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

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

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Primary Completion: 2016-05
• Study Completion: 2017-05-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monobloc	Monobloc	Treatment with an appliance that holds the lower jaw in a fixed protruded position
Bibloc	Bibloc	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)

Primary Outcome Measures

Name	Time	Method
Apnoea-Hypopnea-Index (AHI)	9 weeks after start of study	AHI defined by American Academy of Sleep Medicine (AASM)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Västmanland County Hospitals; 🇸🇪 Västerås, Västmanland, Sweden

Postgraduate Dental Education Center; 🇸🇪 Örebro, Sweden