Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 60 Years|
- - Psoriatic patients that are treated in our institute.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|HaEmek Medical Center, Israel|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Miki Paker, MD|
|Principal Investigator Affiliation||haemek medical center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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 fills a dizziness handicap inventory questionnaire.
Active Comparator: psoriatic patients
psoriatic patients that are recruited from the dermatology clinic. This arm will undergo audiovestibular evaluation.
Active Comparator: healthy volunteers
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
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.