Somnodent vs Herbst in Mild and Moderate OSA Patients
COSH
A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 13, 2016
April 1, 2016
2.3 years
March 14, 2016
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Epworth Sleeping Scale
12 months
Functional Outcome of Sleep Questionnaire
12 months
Blood pressure
12 months
Euroqol (EQ-5D-3L)
12 months
Other Outcomes (1)
Heart Rate
12 months
Study Arms (2)
Oral appliance therapy; Somnodent®
ACTIVE COMPARATORSomnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable.
Oral appliance therapy; Herbst®
ACTIVE COMPARATORHerbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable.
Interventions
Eligibility Criteria
You may qualify if:
- years and older
- Ability to speak, read, and write Dutch.
- Ability to follow-up.
- Ability to use a computer with internet connection for online questionnaires.
- Diagnosis with symptomatic mild or moderate OSA (5 \< AHI \< 30).
- Expected to maintain current lifestyle (sports, medicine, diet, etc.)
You may not qualify if:
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- Medication used/related to sleeping disorders.
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- Temporomandibular disorders (based on the function examination of the masticatory system).
- Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, Periodic Limb Movement Disorder, Narcolepsy).
- Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Inability to provide informed consent.
- simultaneous use of other modalities to treat OSA.
- Previous treatment with a MAD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center Amsterdam
Amsterdam, 1105 AZ, Netherlands
Related Publications (4)
Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.
PMID: 15575799BACKGROUNDHoekema 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.
PMID: 15187032RESULTShi 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.
PMID: 37589748DERIVEDShi 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.
PMID: 36928350DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 31, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2018
Study Completion
July 1, 2018
Last Updated
April 13, 2016
Record last verified: 2016-04