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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Somnodent® (Oral appliance therapy); Device: Herbst® (Oral appliance therapy)

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maurits de Ruiter, DDS; Phone Number: 0031205662300; Email: m.h.deruiter@amc.nl
• Study Contact Backup: Name: Jan de Lange, MD, DDS, PhD; Email: j.delange@amc.uva.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Academic Medical Center Amsterdam
    • Contact: Maurits de Ruiter, DMD; Phone Number: 0031205662300; Email: m.h.deruiter@amc.nl
    • Contact: Jan de Lange, MD, DMD, PhD; Email: j.delange@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral appliance therapy; Somnodent®; Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable.	Device: Somnodent® (Oral appliance therapy)
Active Comparator: Oral appliance therapy; Herbst®; Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable.	Device: Herbst® (Oral appliance therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypnea-Index (AHI)	AHI is measured with polysomnography in hospital	12 months
Oxygen-desaturation-Index	ODI is measured with polysomnography in hospital	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	physical examination	12 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Academic Centre for Dentistry in Amsterdam

Publications and helpful links

General Publications

• Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Oral Appliance Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: NL44085.018.13