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

H

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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