A Study to Determine the Feasibility of Doppler Ultrasound of Large Arterial Systems of the Brain as Vascular Involvement Markers in Presbyacusis and Presbyvestibulopathy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-005807
Sponsor Protocol Number: 19-005807
About this study
The purpose of this study is to benchmark the feasibility of carotid artery biomechanical analysis and vertebral-basilar Transcranial Doppler (TCD) as markers of vascular involvement in presbyacusis and presbyvestibulopathy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 60 years old.
- Vascular - high-grade (over 75%) carotid stenosis
Audiology - Auditory:
- Presbycusis with older-normal phenotype audiograms (low-to-mid frequency <20 dB hearing level (HL) and slightly elevated thresholds for higher frequencies);
- Age-related hearing loss with metabolic phenotype audiograms (mild, flat hearing losses at lower frequencies and gradually sloping hearing loss at higher frequencies);
- Age-related hearing loss with metabolic + sensory phenotype (with mild, flat hearing loss at lower frequencies (the metabolic component) and steeply sloping hearing loss at higher frequencies (the sensory component);
- ± Poor speech perception in noise deviated from the magnitude of hearing thresholds.
Audiology - Vestibular
- Presbyvestibulopathy: Based on the Classification Committee of the Bárány Society.
- Chronic vestibular syndrome (at least 3 months duration) with at least 2 of the following symptoms (Not better accounted for by any eare disease or disorder):
- Postural imbalance or positional vertigo with
- Gait disturbance;
- Chronic dizziness;
- Recurrent falls.
- Mild bilateral peripheral vestibular hypofunction documented by at least 1 of the following:
- VOR gain measured by video-HIT between 0.6 and 0.83 bilaterally;
- VOR gain between 0.1 and 0.3 upon sinusoidal stimulation on a rotatory chair (0.1 Hz, Vmax = 50-60°/sec);
- Reduced caloric response (sum of bithermal maximum peak SPV on each side between 6 and 25°/sec).
Exclusion Criteria:
- Patients with a previous surgical carotid intervention.
- Patients with ophthalmologic peripheral disorders.
- Patients with mild cognitive decline and who have anxiety or depression.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Houssam Farres, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available