PsoriasisMPNCT03865030
The Inner Ear Function in Psoriatic Patients
A study testing audiovestibular function in people with Psoriasis, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- audiovestibular function
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Psoriatic patients that are treated in our institute.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audiovestibular Manifestations in Patients With Psoriasis
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. .
Read the 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.
- Conditions
- Psoriasis
- Being tested
- audiovestibular function
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| psoriatic patients | Active comparator | psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation. Receives: 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. Receives: Device: audiovestibular function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing test
Determining the threshold of each measured tone in decibel units.
Measured: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Hearing test
Determining the speech threshold in decibel units.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 2 weeks after recruitment. estimation time of the outcome is 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paker Miki, HaEmek Medical Center, Israel
- Investigators
- Miki Paker, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865030
- Sponsor's protocol ID
- 0019-19
- Acronym
- MP
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2019
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 17310004Halligan 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.
PubMed 17075400Bayazit 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.
PubMed 17409782Dagli 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.
PubMed 17094003Yen 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.
PubMed 25687690Vir 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.
PubMed 30280411
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovestibular Manifestations in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT03865030
- Acronym / sponsor ID
- MP / 0019-19
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the participants are divided into 2 groups: psoriatic patients and healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| psoriatic patients | Active comparator | Device: audiovestibular functionpsoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation. |
| healthy volunteers | Active comparator | Device: audiovestibular functionHealthy volunteers that are members of the hospital staff and will be recruited from the hospital. This arm will undergo audiovestibular evaluation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Psoriatic patients that are treated in our institute.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audiovestibular functionHearing 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. | Device | healthy volunteers, psoriatic patients |
Primary outcome
Hearing test
Time frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Determining the threshold of each measured tone in decibel units.
Hearing test
Time frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Determining the speech threshold in decibel units.
Tympanometry
Time frame: 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)
Otoacoustic emission
Time frame: 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.
Video head impulse test
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 17310004Pariser 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.
- Background: PubMed 17075400Halligan 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.
- Background: PubMed 17409782Bayazit 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.
- Background: PubMed 17094003Dagli 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.
- Background: PubMed 25687690Yen 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.
- Background: PubMed 30280411Vir 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miki Paker, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audiovestibular function in people with Psoriasis, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing test (time frame: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865030, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.