Somnodent vs Herbst in Mild and Moderate OSA Patients (COSH)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Unknown; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Device: Somnodent® (Oral appliance therapy); Device: Herbst® (Oral appliance therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT02724865

NL44085.018.13

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Oral appliance therapy; Somnodent®

Active Comparator group

Description:

Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable.

Treatment:

Device: Somnodent® (Oral appliance therapy)

Oral appliance therapy; Herbst®

Active Comparator group

Description:

Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable.

Treatment:

Device: Herbst® (Oral appliance therapy)