Obstructive Sleep ApneaNCT02148510
Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices
A study testing Monobloc and Bibloc in people with Obstructive Sleep Apnea, run by Uppsala University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Monobloc and Bibloc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 2 sitesSweden
- Study dates
- May 2014to 15 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Postgraduate Dental Education Center
Örebro, 70111
Västmanland County Hospitals
Västerås, Västmanland County, 72189
About this study
Official title: 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.
Read the 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Monobloc, Bibloc
- Keywords
- human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism, cost
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoblocDevice
Also called Mandibular protruding device
Construction fitted to upper and lower jaw
BiblocDevice
Also called Narval
Biblock construction
| Study group | Role | What they receive |
|---|---|---|
| Monobloc | Experimental | Treatment with an appliance that holds the lower jaw in a fixed protruded position Receives: Device: Monobloc |
| Bibloc | Active comparator | 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) Receives: Device: Bibloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnoea-Hypopnea-Index (AHI)
AHI defined by American Academy of Sleep Medicine (AASM)
Measured: 9 weeks after start of study
Secondary outcomes (5)
Oxygen Desaturation Index (ODI)
Number of episodes per hour with arterial oxygen saturation decline of 3% or more
Measured: 9 weeks
Sleepiness
Epworth Sleepiness Scale (ESS)
Measured: 9 weeks and 1 year
Quality of life
Functional Outcomes of Sleep Questionnaire (FOSQ )
Measured: 9 weeks and 1 year
Sleep bruxism
Bruxism episodes during sleep
Measured: 9 weeks
Adverse events
Subject reported and objective investigator observed events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Goran Isacsson, assoc prof, Study chair, Västmanlands County hospital Västerås, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148510
- Sponsor's protocol ID
- Apnea-2
- Other IDs
- Ethical approval #
- Status last verified
- Nov 2017
- First submitted
- 16 May 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29771314
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices
- ClinicalTrials.gov ID
- NCT02148510
- Acronym / sponsor ID
- Apnea-2
- Conditions
- Obstructive Sleep Apnea
- Keywords
- human, sleep apnea, adults, oral appliance, efficacy, safety, polygraphy, bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monobloc | Experimental | Device: MonoblocTreatment with an appliance that holds the lower jaw in a fixed protruded position |
| Bibloc | Active comparator | Device: BiblocBibloc 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonoblocAlso: Mandibular protruding deviceConstruction fitted to upper and lower jaw | Device | Monobloc |
| BiblocAlso: NarvalBiblock construction | Device | Bibloc |
Primary outcome
Apnoea-Hypopnea-Index (AHI)
Time frame: 9 weeks after start of study
AHI defined by American Academy of Sleep Medicine (AASM)
5 secondary outcomes
Oxygen Desaturation Index (ODI)
Time frame: 9 weeks
Sleepiness
Time frame: 9 weeks and 1 year
Quality of life
Time frame: 9 weeks and 1 year
Sleep bruxism
Time frame: 9 weeks
Adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Derived from this study: PubMed 29771314Isacsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Isacsson, assoc prof study chair
Västmanlands County hospital Västerås, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monobloc and Bibloc in people with Obstructive Sleep Apnea, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnoea-Hypopnea-Index (AHI) (time frame: 9 weeks after start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.