The Inner Ear Function in Psoriatic Patients

Psoriasis Clinical Trial

— MP  

Official title:

Audiovestibular Manifestations in Patients With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865030
• Other study ID #: 0019-19
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Israel	Hemek Medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Bayazit YA, Yilmaz M, Gunduz B, Altinyay S, Kemaloglu YK, Onder M, Gurer MA. Distortion product otoacoustic emission findings in Behçet's disease and rheumatoid arthritis. ORL J Otorhinolaryngol Relat Spec. 2007;69(4):233-8. Epub 2007 Apr 4. — View 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. Epub 2006 Nov 9. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Hearing test	Determining the speech threshold in decibel units.	up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Primary	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.
Primary	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.
Primary	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.
Primary	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.