The Inner Ear Function in Psoriatic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-04-01

Brief Summary

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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. .

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

the participants are divided into 2 groups: psoriatic patients and healthy volunteers.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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psoriatic patients

psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.

Group Type ACTIVE_COMPARATOR

audiovestibular function

Intervention Type DEVICE

Hearing test- includes a pure tone audiometry, speech audiometry and discrimination level.

tympanometry- Includes inserting headphones into the participants ears and computer calculation the compliance of the eardrum.

otoacoustic emission: Includes headphones insertion and calculation of the inner ear audiological function.

Video head impulse test.

\- Dizziness handicap inventory questionnaire. questionnaire filled by the participants provides a subjective data regarding the severity of the dizziness.

healthy volunteers

Healthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation.

Group Type ACTIVE_COMPARATOR

audiovestibular function

Intervention Type DEVICE

Hearing test- includes a pure tone audiometry, speech audiometry and discrimination level.

tympanometry- Includes inserting headphones into the participants ears and computer calculation the compliance of the eardrum.

otoacoustic emission: Includes headphones insertion and calculation of the inner ear audiological function.

Video head impulse test.

\- Dizziness handicap inventory questionnaire. questionnaire filled by the participants provides a subjective data regarding the severity of the dizziness.

Interventions

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audiovestibular function

Hearing test- includes a pure tone audiometry, speech audiometry and discrimination level.

tympanometry- Includes inserting headphones into the participants ears and computer calculation the compliance of the eardrum.

otoacoustic emission: Includes headphones insertion and calculation of the inner ear audiological function.

Video head impulse test.

\- Dizziness handicap inventory questionnaire. questionnaire filled by the participants provides a subjective data regarding the severity of the dizziness.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes