Dysfunction of Vestibular SystemNCT01383642
Physiology of Vestibular Dysfunction and Clinical Implications
An observational study of Dysfunction of Vestibular System and Accidental Falls, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysfunction of Vestibular System, Accidental Falls, Frailty
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2018
- Phase
- Observational
- 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 70 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: community-dwelling adults age >70
Who may be able to join
- Participant's age is 70 years and over?
- Participant is willing and able to give informed consent?
Who cannot join
- Participant has diabetes mellitus
- Participant has blindness, limited neck range of motion or cervical spine instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Dysfunction of Vestibular System, Accidental Falls, Frailty
- Being tested
- No intervention, observational study
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| individuals age >=70 | Not described Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
vestibular function
Measured: baseline
Secondary outcomes (1)
Number of participants who report one or more falls in a one-year follow-up period
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction of Vestibular SystemStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383642
- Sponsor's protocol ID
- NA_00035747-70
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2011
- Last updated
- 24 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Vestibular Dysfunction and Clinical Implications
- ClinicalTrials.gov ID
- NCT01383642
- Acronym / sponsor ID
- NA_00035747-70
- Conditions
- Dysfunction of Vestibular System, Accidental Falls, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2010 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Jun 2011 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individuals age >=70 | – | Other: No intervention, observational study |
Who may qualify
- Ages
- 70 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- community-dwelling adults age >70
Key inclusion criteria (2 listed)
- Participant's age is 70 years and over?
- Participant is willing and able to give informed consent?
Key exclusion criteria (2 listed)
- Participant has diabetes mellitus
- Participant has blindness, limited neck range of motion or cervical spine instability
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 |
|---|---|---|
| No intervention, observational study | Other | individuals age >=70 |
Primary outcome
vestibular function
Time frame: baseline
1 secondary outcome
Number of participants who report one or more falls in a one-year follow-up period
Time frame: one year
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 24 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunction of Vestibular System and Accidental Falls, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 2 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 24 Aug 2018. 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 United States. 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?
vestibular function (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018.