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The Inner Ear Function in Psoriatic Patients

Audiovestibular Manifestations in Patients With Psoriasis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03865030
Acronym
MP
Enrollment
63
Registered
2019-03-06
Start date
2019-03-01
Completion date
2022-04-01
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

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

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.

Interventions

DEVICEaudiovestibular 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.

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hearing testup to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.Determining the threshold of each measured tone in decibel units.
Tympanometryup 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)
Otoacoustic emissionup 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.
Video head impulse testup 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
Dizziness handicap inventoryup 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026