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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02763813
• Other study ID #: 2010/05
• Status: Terminated
• Phase: N/A
• First received: April 19, 2016
• Last updated: October 13, 2016
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de Sécurité Sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Herbst (propulsion type oral appliance)
Oral appliance
• Retention type appliance (ORM)

Locations

Country	Name	City	State
France	Hôpital FOCH	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)		12 months	No