Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academic Centre for Dentistry in Amsterdam | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at present time. Different oral appliances are available, but most used is the mandibular advancement device (MAD). This study focuses on two different types of MAD: the classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to regulate the open space; and the Somnodent, which consists of two separate splints, fixed on the mandible and the maxilla, but has no iron bar attached.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral appliance therapy; SomnodentĀ® | Active Comparator | Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable. |
|
| Oral appliance therapy; HerbstĀ® | Active Comparator | Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SomnodentĀ® (Oral appliance therapy) | Device |
| ||
| HerbstĀ® (Oral appliance therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypnea-Index (AHI) | AHI is measured with polysomnography in hospital | 12 months |
| Oxygen-desaturation-Index | ODI is measured with polysomnography in hospital | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleeping Scale | Questionnaire | 12 months |
| Functional Outcome of Sleep Questionnaire | Questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | physical examination | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurits de Ruiter, DDS | Contact | 0031205662300 | m.h.deruiter@amc.nl | |
| Jan de Lange, MD, DDS, PhD | Contact | j.delange@amc.uva.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center Amsterdam | Recruiting | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15575799 | Background | Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6. | |
| 15187032 | Result | Hoekema A, Stegenga B, De Bont LG. Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review. Crit Rev Oral Biol Med. 2004 Jun 4;15(3):137-55. doi: 10.1177/154411130401500303. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Blood pressure | physical examination | 12 months |
| Euroqol (EQ-5D-3L) | Questionnaire | 12 months |
| 37589748 | Derived | Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Effects of mandibular advancement devices on upper airway dimensions in obstructive sleep apnea: responders versus non-responders. Clin Oral Investig. 2023 Sep;27(9):5649-5660. doi: 10.1007/s00784-023-05186-w. Epub 2023 Aug 17. |
| 36928350 | Derived | Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |