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

Hopital Foch

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: Retention type appliance (ORM); Device: Herbst (propulsion type oral appliance)

Study type: Interventional

Funder types: Other

Identifiers

NCT02763813

2010/05

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Propulsion type appliance (Herbst)

Experimental group

Treatment:

Device: Herbst (propulsion type oral appliance)

Retention type appliance (ORM)

Active Comparator group

Description:

Retention type appliance

Treatment:

Device: Retention type appliance (ORM)