Somnodent vs Herbst in Mild and Moderate OSA Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral appliance therapy; Somnodent®

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

Group Type ACTIVE_COMPARATOR

Somnodent® (Oral appliance therapy)

Intervention Type DEVICE

Oral appliance therapy; Herbst®

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

Group Type ACTIVE_COMPARATOR

Herbst® (Oral appliance therapy)

Intervention Type DEVICE

Interventions

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Somnodent® (Oral appliance therapy)

Intervention Type DEVICE

Herbst® (Oral appliance therapy)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No