The Inner Ear Function in Psoriatic Patients (MP)
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
audiovestibular function
Sponsored by
About this trial
This is an interventional diagnostic trial for Psoriasis
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.
Sites / Locations
- Hemek Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
psoriatic patients
healthy volunteers
Arm Description
psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.
Healthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation.
Outcomes
Primary Outcome Measures
Hearing test
Determining the threshold of each measured tone in decibel units.
Hearing test
Determining the speech threshold in decibel units.
Tympanometry
Determining the type of tympanometry ( one out of the 3 possible options:A,B,C)
Otoacoustic emission
Determining existence or abscence of physiologic otoacoustic emissions in 500, 1000, 2000 Herts.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03865030
First Posted
March 3, 2019
Last Updated
April 3, 2022
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03865030
Brief Title
The Inner Ear Function in Psoriatic Patients
Acronym
MP
Official Title
Audiovestibular Manifestations in Patients With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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:
auditory function examination: hearing test (that includes pure tone audiometry, speech audiometry and discrimination level), tympanometry and otoacoustic emissions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psoriatic patients
Arm Type
Active Comparator
Arm Description
psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
Healthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation.
Intervention Type
Device
Intervention Name(s)
audiovestibular function
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hearing test
Description
Determining the threshold of each measured tone in decibel units.
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Title
Hearing test
Description
Determining the speech threshold in decibel units.
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Title
Tympanometry
Description
Determining the type of tympanometry ( one out of the 3 possible options:A,B,C)
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
Title
Otoacoustic emission
Description
Determining existence or abscence of physiologic otoacoustic emissions in 500, 1000, 2000 Herts.
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 3 minutes.
Title
Video head impulse test
Description
Measuring the velocity of eye movement compared to velocity of the head while the head is thrusted. The measured units are degrees/ seconds
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Title
Dizziness handicap inventory
Description
A questionnaire filled out by the participant, assesses subjectively the level of dizziness from which the patient suffers. Score varies between 0-100
Time Frame
up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hemek Medical center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
17310004
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.
Results Reference
background
PubMed Identifier
17075400
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.
Results Reference
background
PubMed Identifier
17409782
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.
Results Reference
background
PubMed Identifier
17094003
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.
Results Reference
background
PubMed Identifier
25687690
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.
Results Reference
background
PubMed Identifier
30280411
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.
Results Reference
background
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The Inner Ear Function in Psoriatic Patients
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