NCT03295864

Brief Summary

The aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a Chiari type I malformation and healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 14, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

September 14, 2017

Last Update Submit

September 8, 2021

Conditions

Arnold-Chiari Malformation, Type 1

Keywords

Arnold-Chiari Malformation, Type 1Multifrequency tympanometryInner ear pressure

Outcome Measures

Primary Outcomes (1)

  • Width of conductance tympanograms at 2 kHz measurement

    Inclusion

Secondary Outcomes (6)

  • Multifrequency tympanometry

    Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

  • Resonance frequency

    Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

  • Audiometric parameters

    Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

  • Otological symptoms

    Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

  • Pain measurement with Headache Impact Test

    Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

  • +1 more secondary outcomes

Study Arms (2)

Patients with Chiari type 1 malformation

EXPERIMENTAL

Tympanometry measurement at inclusion and 6 months after surgery

Diagnostic Test: Multifrequency tympanometry at InclusionDiagnostic Test: Multifrequency tympanometry 6 month after surgery

Healthy volunteers

EXPERIMENTAL

Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).

Diagnostic Test: Multifrequency tympanometry at Inclusion

Interventions

Multifrequency tympanometry at InclusionDIAGNOSTIC_TEST

Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion

Healthy volunteersPatients with Chiari type 1 malformation
Multifrequency tympanometry 6 month after surgeryDIAGNOSTIC_TEST

Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient

Patients with Chiari type 1 malformation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chiari type I malformation proved at MRI or CT-scan with an indication of cranio cervical decompression.
  • Patients between 18 and 60 years old.
  • Patient should benefit of the national health care system
  • Agreement of the patient
  • Between 18 and 60 years old.
  • Free of otologic pathology
  • Benefit of the national health care system
  • Agreement of the volunteers

You may not qualify if:

  • Acute hydrocephaly
  • Other type of Chiari disease (induced…)
  • Medical history of neurosurgery
  • Contraindication for MRI
  • Cophosis
  • Chronic otitis
  • Medical history of ontological surgery
  • Tympanic perforation
  • Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with abolition of stapedial reflex
  • Pregnant women or nursing women
  • Protected adults by French laws
  • Medical history of neurosurgery
  • Cophosis
  • Chronic otitis
  • Medical history of ontological surgery
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Antoine BENARD, MD

    USMR - CHU de Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 28, 2017

Study Start

December 20, 2017

Primary Completion

February 17, 2020

Study Completion

February 17, 2020

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

FR(1)