An interventional study of audiovestibular function in Psoriasis, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic
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. .
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:
vestibular function examination:
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.
Device: audiovestibular function
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.
Hearing test
Determining the threshold of each measured tone in decibel units.
Time frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Hearing test
Determining the speech threshold in decibel units.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.
Plan to share: No — 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.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel