- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148510
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Örebro, Sweden, 70111
- Postgraduate Dental Education Center
-
-
Västmanland
-
Västerås, Västmanland, Sweden, 72189
- Västmanland County Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monobloc
Treatment with an appliance that holds the lower jaw in a fixed protruded position
|
Construction fitted to upper and lower jaw
Other Names:
|
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)
|
Biblock construction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apnoea-Hypopnea-Index (AHI)
Time Frame: 9 weeks after start of study
|
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)
Time Frame: 9 weeks
|
Number of episodes per hour with arterial oxygen saturation decline of 3% or more
|
9 weeks
|
Sleepiness
Time Frame: 9 weeks and 1 year
|
Epworth Sleepiness Scale (ESS)
|
9 weeks and 1 year
|
Quality of life
Time Frame: 9 weeks and 1 year
|
Functional Outcomes of Sleep Questionnaire (FOSQ )
|
9 weeks and 1 year
|
Sleep bruxism
Time Frame: 9 weeks
|
Bruxism episodes during sleep
|
9 weeks
|
Adverse events
Time Frame: 1 year
|
Subject reported and objective investigator observed events
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of care
Time Frame: 1 year
|
Total cost calculation including the device, repairs and adjustments and consumption of dentist time
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Goran Isacsson, assoc prof, Västmanlands County hospital Västerås, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Apnea-2
- Ethical approval # (Registry Identifier: DNR 2014/021)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Monobloc
-
The University of Hong KongUnknown
-
CHU de Quebec-Universite LavalZimmer BiometCompletedUnilateral Primary Osteoarthritis of KneeCanada
-
Zimmer BiometActive, not recruitingPain | Arthritis | OsteoarthrosisSweden, Finland, Denmark