Integrative Study of Vestibular Pathology

NCT05525728 | Unknown

• 1 other identifier: 2020-A02956-33
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life). The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

Conditions

Dizziness; Syndrome

Keywords

posture; vertigo; cognition; emotion; physiotherapist; vestibular system; balance

Outcome Measures

Primary Outcomes (5)

• Posture

  postural measurement

  through follow-up, an average of 6 months

• Cognition

  Spatial cognitive performance in a calibrated virtual radial maze

  through follow-up, an average of 6 months

• Personnality characteristic

  Evaluation of the BIg Five inventory test

  through follow-up, an average of 6 months

• Sleep

  Quantitative sleep recording

  through follow-up, an average of 6 months

• Emotion

  Anxiety measurement via questionnary

  through follow-up, an average of 6 months

Study Arms (1)

patient

OTHER

One cohort of patients

Other: Neurosensory

Interventions

Neurosensory OTHER

Physiological and neurophysiological investigations

patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient (18-80 years old)
• Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria

You may not qualify if:

• Subjects under 18 years of age
• Pregnant or breastfeeding women,
• Persons in an emergency situation or unable to give their consent, including adults under guardianship
• Person under legal protection
• Patient presenting a vertigo or postural disorders of non vestibular etiology
• Persons deprived of liberty, minors, protected adults,
• Patients with an intercurrent neurological pathology including cerebellar pathology

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (2)

Caen University Hospital

Caen, 14033, France

RECRUITING

Frédéric Xavier

Vitrolles, 13127, France

RECRUITING

MeSH Terms

Conditions

Dizziness; Syndrome; Vertigo

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease; Pathologic Processes; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: a group of patient suffering from vestibular pathology will be investigated regardless the etiology of the vertigo or dizziness

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 2, 2022
• Study Start: June 18, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)