NCT03865030

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2.9 years

First QC Date

March 3, 2019

Last Update Submit

April 3, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (6)

  • 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.

Study Arms (2)

psoriatic patients

ACTIVE COMPARATOR

psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.

Device: audiovestibular function

healthy volunteers

ACTIVE COMPARATOR

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

Interventions

audiovestibular functionDEVICE

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.

healthy volunteerspsoriatic patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Psoriatic patients that are treated in our institute.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemek Medical center

Afula, 1834111, Israel

Location

Related Publications (6)

  • Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on disease severity. Arch Dermatol. 2007 Feb;143(2):239-42. doi: 10.1001/archderm.143.2.239.

    PMID: 17310004BACKGROUND

  • Halligan CS, Bauch CD, Brey RH, Achenbach SJ, Bamlet WR, McDonald TJ, Matteson EL. Hearing loss in rheumatoid arthritis. Laryngoscope. 2006 Nov;116(11):2044-9. doi: 10.1097/01.mlg.0000241365.54017.32.

    PMID: 17075400BACKGROUND

  • Bayazit YA, Yilmaz M, Gunduz B, Altinyay S, Kemaloglu YK, Onder M, Gurer MA. Distortion product otoacoustic emission findings in Behcet's disease and rheumatoid arthritis. ORL J Otorhinolaryngol Relat Spec. 2007;69(4):233-8. doi: 10.1159/000101544. Epub 2007 Apr 4.

    PMID: 17409782BACKGROUND

  • Dagli M, Sivas Acar F, Karabulut H, Eryilmaz A, Erkol Inal E. Evaluation of hearing and cochlear function by DPOAE and audiometric tests in patients with ankylosing spondilitis. Rheumatol Int. 2007 Apr;27(6):511-6. doi: 10.1007/s00296-006-0249-6. Epub 2006 Nov 9.

    PMID: 17094003BACKGROUND

  • Yen YC, Lin YS, Weng SF, Lai FJ. Risk of sudden sensorineural hearing loss in patients with psoriasis: a retrospective cohort study. Am J Clin Dermatol. 2015 Jun;16(3):213-20. doi: 10.1007/s40257-015-0117-9.

    PMID: 25687690BACKGROUND

  • Vir D, Sharma P, Mahajan R, Dogra S, Bakshi J, Panda NK. Investigation of high-frequency hearing loss and outer hair cell function of the cochlea in patients with psoriasis: a case-control study. Clin Exp Dermatol. 2019 Jul;44(5):520-523. doi: 10.1111/ced.13805. Epub 2018 Oct 2.

    PMID: 30280411BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Miki Paker, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Dr. Miki Paker

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 6, 2019

Study Start

March 1, 2019

Primary Completion

February 1, 2022

Study Completion

April 1, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

IL(1)