Audiovestibular Manifestations in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Otoacoustic emission
研究概览
简要总结
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. .
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Psoriatic patients that are treated in our institute.
排除标准
- •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.
结局指标
主要结局
Otoacoustic emission
时间窗: 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.
Tympanometry
时间窗: 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)
Video head impulse test
时间窗: 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
时间窗: 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
Hearing test
时间窗: up to 2 weeks after recruitment. estimation time of the outcome is 10 minutes.
Determining the threshold of each measured tone in decibel units.
次要结局
未报告次要终点
研究者
Paker Miki
principal investigator, Dr. Miki Paker
HaEmek Medical Center, Israel