Clinical trial NCT02724865: Somnodent vs Herbst in Mild and Moderate OSA Patients
Official title: A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Oral Appliance Therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Academic Centre for Dentistry in Amsterdam
First posted: 2016-03-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-hypnea-Index (AHI)
timeFrame: 12 months
measure: Oxygen-desaturation-Index
timeFrame: 12 months
Secondary outcomes:
measure: Epworth Sleeping Scale
timeFrame: 12 months
measure: Functional Outcome of Sleep Questionnaire
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Euroqol (EQ-5D-3L)
timeFrame: 12 months
Other outcomes:
measure: Heart Rate
timeFrame: 12 months
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
Study officials:
References:
citation: Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.
citation: 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. doi: 10.1177/154411130401500303.