The Inner Ear Function in Psoriatic Patients (MP)

April 3, 2022 updated by: Paker Miki, HaEmek Medical Center, Israel

Audiovestibular Manifestations in Patients With Psoriasis

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Hemek Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: psoriatic patients
psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.
Device: 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.
ACTIVE_COMPARATOR: healthy volunteers
Healthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing test
Time Frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Determining the threshold of each measured tone in decibel units.
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
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.
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
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)
up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
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.
up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
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
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
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
up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Miki Paker, MD, Haemek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (ACTUAL)

March 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0019-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will be collected in the principal investigator computer for a period of 7 years.

The computer has a personal password and the computer if located inside a locked room.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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