Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome

NCT ID: NCT02763813

Last Updated: 2016-10-14

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

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-02-28

Brief Summary

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Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.

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

SINGLE

Participants

Study Groups

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Propulsion type appliance (Herbst)

Group Type EXPERIMENTAL

Herbst (propulsion type oral appliance)

Intervention Type DEVICE

Oral appliance

Retention type appliance (ORM)

Retention type appliance

Group Type ACTIVE_COMPARATOR

Retention type appliance (ORM)

Intervention Type DEVICE

Interventions

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Herbst (propulsion type oral appliance)

Oral appliance

Intervention Type DEVICE

Retention type appliance (ORM)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sufficient teeth to allow wearing of the device
* Mild to severe OSAS
* Ability to answer the questionnaires
* No concomitant CPAP treatment
* BMI inferior to 32 kg/m2

Exclusion Criteria

* Important dental or parodontal disease
* Central sleep apnea
* Jaw opening limitations
* Temporo-mandibular joint dysfunction
* Major gag reflex precluding the long-term use of the device
* Major or unstable cardiovascular or pulmonary disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc BLUMEN, MD

Role: STUDY_CHAIR

Hôpital FOCH 40, rue Worth 92150 Suresnes

Locations

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Hôpital FOCH

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2010/05

Identifier Type: -

Identifier Source: org_study_id

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