The Inner Ear Function in Psoriatic Patients

Study Overview
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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. .

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: 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.

Official Title
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Audiovestibular Manifestations in Patients With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Device: audiovestibular function


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: psoriatic patients<br>psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation. | Device: audiovestibular function<br>* 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.<br>|
| Active Comparator: healthy volunteers<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing test | 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 | Determining the speech threshold in decibel units. | up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes. | 
| Tympanometry | 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 | 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 | 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 | 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. |