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

NCT ID: NCT02148510

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-15

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

Conditions

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Obstructive Sleep Apnea

Keywords

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human sleep apnea adults oral appliance efficacy safety polygraphy bruxism cost

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Monobloc

Treatment with an appliance that holds the lower jaw in a fixed protruded position

Group Type EXPERIMENTAL

Monobloc

Intervention Type DEVICE

Construction fitted to upper and lower jaw

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)

Group Type ACTIVE_COMPARATOR

Bibloc

Intervention Type DEVICE

Biblock construction

Interventions

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Monobloc

Construction fitted to upper and lower jaw

Intervention Type DEVICE

Bibloc

Biblock construction

Intervention Type DEVICE

Other Intervention Names

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Mandibular protruding device Narval

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Goran Isacsson, assoc prof

Role: STUDY_CHAIR

Västmanlands County hospital Västerås, Sweden

Locations

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Västmanland County Hospitals

Västerås, Västmanland County, Sweden

Site Status

Postgraduate Dental Education Center

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 29771314 (View on PubMed)

Other Identifiers

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Ethical approval #

Identifier Type: REGISTRY

Identifier Source: secondary_id

Apnea-2

Identifier Type: -

Identifier Source: org_study_id