An interventional study of Multifrequency tympanometry at Inclusion and Multifrequency tympanometry 6 month after surgery in Arnold-Chiari Malformation, Type 1, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
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.
Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type I malformation is responsive in perturbation of the cerebro spinal fluid flow at the cranio-cervical junction. Those perturbations caused headaches, and various otological symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis...). The surgical treatment consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological perturbations especially alteration of the vestibular test.
In the literature, hearing performance could be normalized after posterior fossa decompression. Furthermore, the multifrequency tympanometry measurement and particularly the width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid pressure have consequences on the pressure of the perilymph.
Investigator's hypothesis is that tympanometry (conductance) could be an effective test to show the variation of the cerebro spinal fluid pressure.
34 studies on the registry are indexed under Arnold-Chiari Malformation; 10 are open to participants now.
This study's enrollment of 49 is close to the median of 45 across 18 interventional studies indexed under Arnold-Chiari Malformation.
Browse Arnold-Chiari Malformation studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Inclusion criteria for healthy volunteers:
Exclusion criteria:
Exclusion criteria for healthy volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tympanometry measurement at inclusion and 6 months after surgery
Diagnostic Test: Multifrequency tympanometry at Inclusion · Diagnostic Test: Multifrequency tympanometry 6 month after surgery
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
Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion
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
Width of conductance tympanograms at 2 kHz measurement
Time frame: Inclusion
Multifrequency tympanometry
Time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Resonance frequency
Time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Audiometric parameters
Time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Otological symptoms
Time frame: 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
Time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Cerebro spinal fluid pressure of the cranio cervical junction
Time frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Ran from Dec 2017 to primary completion in Feb 2020, 25 months.
Of 16 interventional studies with no phase under Arnold-Chiari Malformation, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's 25 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux →