Clinical trial NCT03865030: The Inner Ear Function in Psoriatic Patients
Official title: Audiovestibular Manifestations in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hearing test
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
measure: Hearing test
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
measure: Tympanometry
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
measure: Otoacoustic emission
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
measure: Video head impulse test
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
measure: Dizziness handicap inventory
timeFrame: up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Hemek Medical center
Study officials:
affiliation: haemek medical center
name: Miki Paker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.