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

Primary Purpose

Obstructive Sleep Apnea

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Somnodent® (Oral appliance therapy)

Herbst® (Oral appliance therapy)

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Oral Appliance Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Academic Medical Center AmsterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oral appliance therapy; Somnodent®

Oral appliance therapy; Herbst®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Apnea-hypnea-Index (AHI)

AHI is measured with polysomnography in hospital

Oxygen-desaturation-Index

ODI is measured with polysomnography in hospital

Secondary Outcome Measures

Epworth Sleeping Scale

Questionnaire

Functional Outcome of Sleep Questionnaire

Questionnaire

Blood pressure

physical examination

Euroqol (EQ-5D-3L)

Questionnaire

Full Information

NCT ID

NCT02724865

First Posted

March 14, 2016

Last Updated

April 12, 2016

Sponsor

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

Collaborators

Academic Centre for Dentistry in Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT02724865

Brief Title

Somnodent vs Herbst in Mild and Moderate OSA Patients

Acronym

COSH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Academic Centre for Dentistry in Amsterdam

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Oral Appliance Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral appliance therapy; Somnodent®

Arm Type

Active Comparator

Arm Description

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

Arm Title

Oral appliance therapy; Herbst®

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Somnodent® (Oral appliance therapy)

Intervention Type

Device

Intervention Name(s)

Herbst® (Oral appliance therapy)

Primary Outcome Measure Information:

Title

Apnea-hypnea-Index (AHI)

Description

AHI is measured with polysomnography in hospital

Time Frame

12 months

Title

Oxygen-desaturation-Index

Description

ODI is measured with polysomnography in hospital

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Epworth Sleeping Scale

Description

Questionnaire

Time Frame

12 months

Title

Functional Outcome of Sleep Questionnaire

Description

Questionnaire

Time Frame

12 months

Title

Blood pressure

Description

physical examination

Time Frame

12 months

Title

Euroqol (EQ-5D-3L)

Description

Questionnaire

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Heart Rate

Description

physical examination

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maurits de Ruiter, DDS

Phone

0031205662300

m.h.deruiter@amc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Jan de Lange, MD, DDS, PhD

j.delange@amc.uva.nl

Facility Information:

Facility Name

Academic Medical Center Amsterdam

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurits de Ruiter, DMD

Phone

0031205662300

m.h.deruiter@amc.nl

First Name & Middle Initial & Last Name & Degree

Jan de Lange, MD, DMD, PhD

j.delange@amc.uva.nl

12. IPD Sharing Statement

Citations:

PubMed Identifier

15575799

Citation

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

Results Reference

background

PubMed Identifier

15187032

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.

Results Reference

result

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Somnodent vs Herbst in Mild and Moderate OSA Patients

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