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Clinical Trials/NCT03865030
NCT03865030
Completed
Not Applicable

Audiovestibular Manifestations in Patients With Psoriasis

HaEmek Medical Center, Israel1 site in 1 country63 target enrollmentMarch 1, 2019
ConditionsPsoriasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psoriasis
Sponsor
HaEmek Medical Center, Israel
Enrollment
63
Locations
1
Primary Endpoint
Otoacoustic emission
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Psoriasis in a systemic disease that effects many systems of the body. few studies examined the hearing function of these patients but the results were inconclusive. No study, however, investigated the vestibular function of psoriatic patients.

In a prospective study, the investigators will compare audiovestibular function between psoriatic patients and healthy volunteers. .

Detailed Description

Whether psoriatic patients have higher risk for developing inner ear dysfunction (hearing loss and dizziness) is an important issue that needs to be elucidated. Awareness to the elevated risk (if there is any) of inner ear impairment, early detection and treatment of the condition may reduce the morbidities resulting from undiagnosed audiovestibular impairment. In a prospective study the investigators will examine the inner ear function (vestibular and auditory) of psoriatic patients and compare it to an healthy, young control group. The study will include 2 groups of participants: psoriatic patients and healthy volunteers. psoriatic patients are recruited from the dermatology clinic while the healthy volunteers are members of the hospital staff. The participants will undergo 2 sets of examinations: 1. auditory function examination: hearing test (that includes pure tone audiometry, speech audiometry and discrimination level), tympanometry and otoacoustic emissions. 2. vestibular function examination: * Video head impulse test: a ten-minute, non- invasive test that includes a computer and a set of goggles worn by the participant. The participants is sitting in front of a wall while wearing the goggles, the investigator moves the participant's head sideways with short, rapid movements. the computer calculates the accuracy and the velocity of the eyes movements. * The participants fills a dizziness handicap inventory questionnaire. The participants from the psoriatic group are recruited from the dermatology clinic. The healthy group participants are members of the hospital staff and are recruited from the hospital.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
April 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paker Miki

principal investigator, Dr. Miki Paker

HaEmek Medical Center, Israel

Eligibility Criteria

Inclusion Criteria

  • Psoriatic patients that are treated in our institute.

Exclusion Criteria

  • Patients suffering from cardiovascular diseases (peripheral vascular disease,congestive heart failure, status post cerebrovascular accident).
  • Conditions that are harmful to the inner ear (chronic renal failure,history of noise exposure, usage of ototoxic drugs, chronic otitis media, ear surgery in the past, significant head trauma in the past, ear drum perforation).
  • participant that complains of vertigo/ dizziness/ unsteadiness.
  • Participant who is/ was suffering from known inner ear disease: meniere disease, acoustic neurinoma, vestibular neuronitis.

Outcomes

Primary Outcomes

Otoacoustic emission

Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.

Determining existence or abscence of physiologic otoacoustic emissions in 500, 1000, 2000 Herts.

Hearing test

Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.

Determining the speech threshold in decibel units.

Tympanometry

Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.

Determining the type of tympanometry ( one out of the 3 possible options:A,B,C)

Video head impulse test

Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.

Measuring the velocity of eye movement compared to velocity of the head while the head is thrusted. The measured units are degrees/ seconds

Dizziness handicap inventory

Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.

A questionnaire filled out by the participant, assesses subjectively the level of dizziness from which the patient suffers. Score varies between 0-100

Study Sites (1)

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