The Inner Ear Function in Psoriatic Patients

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Device: audiovestibular function

• Registration Number: NCT03865030
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Primary Completion: 2022-02-01
• Status Verified: 2022-04
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	audiovestibular function	Healthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation.
psoriatic patients	audiovestibular function	psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.

Primary Outcome Measures

Name	Time	Method
Otoacoustic emission	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.
Hearing test	up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.	Determining the speech threshold in decibel units.
Tympanometry	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)
Video head impulse test	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
Dizziness handicap inventory	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

Trial Locations

Locations (1)

Hemek Medical center; 🇮🇱 Afula, Israel