Somnodent vs Herbst in Mild and Moderate OSA Patients

Phase 4

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Somnodent® (Oral appliance therapy); Device: Herbst® (Oral appliance therapy)

• Registration Number: NCT02724865
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13
• Primary Completion: 2018-05
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral appliance therapy; Somnodent®	Somnodent® (Oral appliance therapy)	Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable.
Oral appliance therapy; Herbst®	Herbst® (Oral appliance therapy)	Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable.

Primary Outcome Measures

Name	Time	Method
Apnea-hypnea-Index (AHI)	12 months	AHI is measured with polysomnography in hospital
Oxygen-desaturation-Index	12 months	ODI is measured with polysomnography in hospital

Secondary Outcome Measures

Name	Time	Method
Euroqol (EQ-5D-3L)	12 months	Questionnaire
Epworth Sleeping Scale	12 months	Questionnaire
Functional Outcome of Sleep Questionnaire	12 months	Questionnaire
Blood pressure	12 months	physical examination

Trial Locations

Locations (1)

Academic Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands