Somnodent vs Herbst in Mild and Moderate OSA Patients

Obstructive Sleep Apnea Clinical Trial

— COSH  

Official title:

A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02724865
• Other study ID #: NL44085.018.13
• Status: Recruiting
• Phase: Phase 4
• First received: March 14, 2016
• Last updated: April 12, 2016
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: April 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Maurits de Ruiter, DDS
• Phone: 0031205662300
• Email: m.h.deruiter[@]amc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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.)

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Somnodent® (Oral appliance therapy)

• Herbst® (Oral appliance therapy)

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Academic Centre for Dentistry in Amsterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Review. — View Citation

Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate	physical examination	12 months	No
Primary	Apnea-hypnea-Index (AHI)	AHI is measured with polysomnography in hospital	12 months	No
Primary	Oxygen-desaturation-Index	ODI is measured with polysomnography in hospital	12 months	No
Secondary	Epworth Sleeping Scale	Questionnaire	12 months	No
Secondary	Functional Outcome of Sleep Questionnaire	Questionnaire	12 months	No
Secondary	Blood pressure	physical examination	12 months	No
Secondary	Euroqol (EQ-5D-3L)	Questionnaire	12 months	No