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

Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02763813

Enrollment

Registered

2016-05-05

Start date

2010-05-31

Completion date

2013-02-28

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

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.

Interventions

DEVICEHerbst (propulsion type oral appliance)

Oral appliance

DEVICERetention type appliance (ORM)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026