Comparison of Two Oral Appliances in the Treatment of Sle... | NCT02763813

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

NCT02763813

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Oct 14, 2016Estimated

Enrollment

4Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Herbst (propulsion type oral appliance)
Retention type appliance (ORM)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

May 4, 2016

First Posted Date

May 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Herbst (propulsion type oral appliance)	Device	Oral appliance	Propulsion type appliance (Herbst)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc BLUMEN, MD	Hôpital FOCH 40, rue Worth 92150 Suresnes	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital FOCH		Suresnes		92150	France

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided