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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Monobloc; Device: Bibloc

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 Type: Interventional
• Enrollment (Actual): 313
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70111
    • Postgraduate Dental Education Center
  • Västmanland
    • Västerås, Västmanland, Sweden, 72189
      • Västmanland County Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monobloc; Treatment with an appliance that holds the lower jaw in a fixed protruded position	Device: Monobloc; Construction fitted to upper and lower jaw; Other Names: Mandibular protruding device
Active Comparator: 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)	Device: Bibloc; Biblock construction; Other Names: Narval

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of care	Total cost calculation including the device, repairs and adjustments and consumption of dentist time	1 year

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Chair: Goran Isacsson, assoc prof, Västmanlands County hospital Västerås, Sweden

Publications and helpful links

General Publications

• Isacsson G, Nohlert E, Fransson AMC, Bornefalk-Hermansson A, Wiman Eriksson E, Ortlieb E, Trepp L, Avdelius A, Sturebrand M, Fodor C, List T, Schumann M, Tegelberg A. Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial. Eur J Orthod. 2019 Jan 23;41(1):80-88. doi: 10.1093/ejo/cjy030.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: safety; efficacy; human; sleep apnea; adults; oral appliance; cost; bruxism; polygraphy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Apnea-2; Ethical approval # (Registry Identifier: DNR 2014/021)