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| ID | Type | Description | Link |
|---|---|---|---|
| Ethical approval # | Registry Identifier | DNR 2014/021 |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monobloc | Experimental | Treatment with an appliance that holds the lower jaw in a fixed protruded position |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monobloc | Device | Construction fitted to upper and lower jaw |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnoea-Hypopnea-Index (AHI) | AHI defined by American Academy of Sleep Medicine (AASM) | 9 weeks after start of study |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of care | Total cost calculation including the device, repairs and adjustments and consumption of dentist time | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Isacsson, assoc prof | Västmanlands County hospital Västerås, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Västmanland County Hospitals | Västerås | Västmanland County | 72189 | Sweden | ||
| Postgraduate Dental Education Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29771314 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 17, 2019 | |
| Reset | Jul 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 17, 2019 | Jul 19, 2019 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Bibloc | Device | Biblock construction |
|
|
| 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 |
| Örebro |
| 70111 |
| Sweden |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |