- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383642
Physiology of Vestibular Dysfunction and Clinical Implications
August 22, 2018 updated by: Johns Hopkins University
Vestibular dysfunction is a known contributor to imbalance and fall risk, and may be a precursor to the frailty phenotype seen in the elderly population.
A recent study found that vestibular dysfunction is common in the US population, and that the prevalence of this impairment increases steeply with age.
However, it is unknown whether the aging process has global effects on the vestibular end-organ or whether specific structures, e.g. the semicircular canals or the otoliths, are selectively impaired.
Moreover, the clinical implications of specific deficits of the vestibular end-organ are unclear.
As such, the aims of this proposed research are: 1) to evaluate whether the normative aging process is predominantly associated with dysfunction of the semicircular canals (as measured by caloric and angular vestibulo-ocular reflex testing) or of the otoliths (as measured by vestibular-evoked myogenic potential (VEMP) testing); 2) to determine if there are any characteristic clinical features associated with the subtypes of vestibular dysfunction; and 3) to assess whether dysfunction of the semicircular canals or of the otoliths is associated with a higher risk of frailty and falls.
The investigators plan to pursue these aims through a cross-sectional and prospective cohort study of a group of individuals age 70 and above.
Vestibular physiologic tests will be administered to all study participants, and test results will be correlated with baseline clinical symptoms and frailty status as well as prospective one-year fall risk.
A greater understanding of vestibular physiologic deficits and clinical implications in older individuals can inform the development of rational vestibular rehabilitation strategies that may more effectively mitigate the frailty phenotype and reduce fall risk.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 95 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
community-dwelling adults age >70
Description
Inclusion Criteria:
- Participant's age is 70 years and over?
- Participant is willing and able to give informed consent?
Exclusion Criteria:
- Participant has diabetes mellitus
- Participant has blindness, limited neck range of motion or cervical spine instability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
individuals age >=70
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
vestibular function
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants who report one or more falls in a one-year follow-up period
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
June 23, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Actual)
August 24, 2018
Last Update Submitted That Met QC Criteria
August 22, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00035747-70
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
University of IcelandLandspitali University HospitalRecruitingFrailty Syndrome | Elective Surgery | Frailty in Adult SurgeryIceland
-
University of NottinghamRecruitingFrailty | Diet | Systemic Inflammatory Response | Dietary Fiber | Frailty at Older Adults | Pre-FrailtyUnited Kingdom
-
Maximilian KönigNot yet recruiting
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Xijing HospitalEnrolling by invitationFrailty SyndromeChina
-
Longeveron Inc.CompletedAging FrailtyUnited States
Clinical Trials on No intervention, observational study
-
Drexel UniversityCompletedOsteoporosisUnited States
-
The Aurum Institute NPCKarolinska Institutet; Ludwig-Maximilians - University of Munich; University... and other collaboratorsUnknownRespiratory Tract Infections | Tuberculosis, PulmonaryMozambique, South Africa, Tanzania, Gambia
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
University Hospital, Basel, SwitzerlandCompletedPostoperative Complications | Intraoperative Complications | Patient Safety | Risk ManagementNew Zealand, Switzerland, United States, Netherlands, Spain, Austria, Turkey, United Kingdom, Australia, Greece, Ireland, Italy
-
Hôpital Necker-Enfants MaladesUnknown
-
University Health Network, TorontoNot yet recruitingCardiac Surgery Requiring Cardiopulmonary Bypass
-
Gulbenkian Institute for Molecular MedicineCUF Tejo Hospital; Hospital CUF Descobertas, Lisbon, Portugal; Hospital da Luz...RecruitingMicrobiome | Colorectal Cancer Screening | Colorectal Cancer (CRC)Portugal
-
The First Affiliated Hospital of Xinxiang Medical...Anyang Cancer Hospital; Xinxiang Central Hospital of Henan province; Inner Huang... and other collaboratorsNot yet recruiting
-
Liverpool School of Tropical MedicineLondon School of Hygiene and Tropical Medicine; Wellcome Trust; University of... and other collaboratorsRecruitingKidney Diseases | Chronic Kidney Diseases | Non-communicable Disease | Non-Communicable Chronic DiseasesMalawi
-
Nanfang Hospital of Southern Medical UniversityThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... and other collaboratorsRecruiting