NCT02763813

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

April 19, 2016

Last Update Submit

October 13, 2016

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)

    12 months

Study Arms (2)

Propulsion type appliance (Herbst)

EXPERIMENTAL
Device: Herbst (propulsion type oral appliance)

Retention type appliance (ORM)

ACTIVE COMPARATOR

Retention type appliance

Device: Retention type appliance (ORM)

Interventions

Herbst (propulsion type oral appliance)DEVICE

Oral appliance

Propulsion type appliance (Herbst)
Retention type appliance (ORM)DEVICE
Retention type appliance (ORM)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Marc BLUMEN, MD

    Hôpital FOCH 40, rue Worth 92150 Suresnes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 5, 2016

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

FR(1)