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NCT Number: NCT03865030

The Inner Ear Function in Psoriatic Patients

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hemek Medical center

Afula, 1834111, Israel

About this study

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:

  • auditory function examination: hearing test (that includes pure tone audiometry, speech audiometry and discrimination level), tympanometry and otoacoustic emissions.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

audiovestibular function

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Audiovestibular Manifestations in Patients With Psoriasis

Acronym: MP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2019
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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