NCT02724865

Somnodent vs Herbst in Mild and Moderate OSA Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Somnodent® (Oral appliance therapy)
DEVICE	Herbst® (Oral appliance therapy)

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-05-01
• Completion: 2018-07-01
• First posted: 2016-03-31
• Last updated: 2016-04-13

Locations

1 site across 1 country: Netherlands