Back to resultsOral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Monobloc
Bibloc
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism, cost
Eligibility Criteria
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
Sites / Locations
- Västmanland County Hospitals
- Postgraduate Dental Education Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monobloc
Bibloc
Arm Description
Treatment with an appliance that holds the lower jaw in a fixed protruded position
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)
Outcomes
Primary Outcome Measures
Apnoea-Hypopnea-Index (AHI)
AHI defined by American Academy of Sleep Medicine (AASM)
Secondary Outcome Measures
Oxygen Desaturation Index (ODI)
Number of episodes per hour with arterial oxygen saturation decline of 3% or more
Sleepiness
Epworth Sleepiness Scale (ESS)
Quality of life
Functional Outcomes of Sleep Questionnaire (FOSQ )
Sleep bruxism
Bruxism episodes during sleep
Adverse events
Subject reported and objective investigator observed events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02148510
Brief Title
Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices
Official Title
Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism, cost
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monobloc
Arm Type
Experimental
Arm Description
Treatment with an appliance that holds the lower jaw in a fixed protruded position
Arm Title
Bibloc
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Monobloc
Other Intervention Name(s)
Mandibular protruding device
Intervention Description
Construction fitted to upper and lower jaw
Intervention Type
Device
Intervention Name(s)
Bibloc
Other Intervention Name(s)
Narval
Intervention Description
Biblock construction
Primary Outcome Measure Information:
Title
Apnoea-Hypopnea-Index (AHI)
Description
AHI defined by American Academy of Sleep Medicine (AASM)
Time Frame
9 weeks after start of study
Secondary Outcome Measure Information:
Title
Oxygen Desaturation Index (ODI)
Description
Number of episodes per hour with arterial oxygen saturation decline of 3% or more
Time Frame
9 weeks
Title
Sleepiness
Description
Epworth Sleepiness Scale (ESS)
Time Frame
9 weeks and 1 year
Title
Quality of life
Description
Functional Outcomes of Sleep Questionnaire (FOSQ )
Time Frame
9 weeks and 1 year
Title
Sleep bruxism
Description
Bruxism episodes during sleep
Time Frame
9 weeks
Title
Adverse events
Description
Subject reported and objective investigator observed events
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Cost of care
Description
Total cost calculation including the device, repairs and adjustments and consumption of dentist time
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Isacsson, assoc prof
Organizational Affiliation
Västmanlands County hospital Västerås, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Västmanland County Hospitals
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Postgraduate Dental Education Center
City
Örebro
ZIP/Postal Code
70111
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29771314
Citation
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.
Results Reference
derived
Learn more about this trial
Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices
We'll reach out to this number within 24 hrs