Vestibular HypofunctionMINDGAPSNCT05391932
Making INformed Decisions in Gaze and Postural Stability: A Pilot Feasibility Study
A study testing MINDGAPS in people with Vestibular Hypofunction, run by University of Montana at 1 site in United States.
Trial summary
The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vestibular Hypofunction
- What is being tested?
- MINDGAPS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reports issues with dizziness or imbalance
- Ability to stand independently
- Presence of peripheral vestibular hypofunction as indicated by examination with video nystagmography, video head impulse testing, or dynamic visual acuity testing.
Who cannot join
- cervical spine disorders
- vertebral or carotid artery dissection
- blindness
- peripheral or central oculomotor palsy
- centrally mediated vestibular dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Montana
Missoula, Montana, 59812
Brian Loyd, PhD, 406-243-4015, Brian.loyd@umontana.edu
Andy Kittelson, PhD, 406-243-4015, Andy.kittelson@umontana.edu
About this study
Official title: Making INformed Decisions in Gaze and Postural Stability (MINDGAPS): A Novel System for Improving Personalized Care and Patient Adherence in Vestibular Rehabilitation
The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. In this investigation the investigators will: 1) assess the preliminary efficacy of a novel intervention system for improving vestibular function and dizziness in community-dwelling older adults, 2) assess the safety and feasibility of the this system, and 3) assess the acceptability and implementation potential of this system, prior to a large-scale, R01-level investigation.
Read the detailed description
Deficits in gaze and postural stability are closely linked with vestibular hypofunction. These deficits result in dizziness and poor balance, increasing the risk for falls and other poor health outcomes. Vestibular hypofunction occurs with several conditions and is increasingly prevalent with advancing age. An estimated 85% of people over the age of 80 experience vestibular hypofunction. As with many age-related health challenges (e.g. sarcopenia, osteoporosis, cardiovascular disease), exercise is widely recommended to remediate the effects of vestibular hypofunction. Vestibular rehabilitation has demonstrated efficacy at improving vestibular hypofunction in tightly controlled clinical trials, but the effectiveness in practice is limited by two major barriers: 1) reduced patient adherence to the exercise program, and 2) inability to precisely assess vestibular function. These are overlapping challenges; lack of access to vestibular function assessments impedes effective dosing of rehabilitation as well as monitoring of patient adherence and progress. Thus, personalization and monitoring-essential ingredients of nearly any health or exercise regimen-are functionally missing in vestibular rehabilitation practice.
For this proposal, the investigators have developed the Making INformed Decisions in Gaze and Postural Stability (MINDGAPS) system, which utilizes wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises. Additionally, MINDGAPS leverages NIH Toolbox data to display patient status compared to normative values and to indicate progress over time relative to measurement error. This enables the application of two innovative behavioral science principles aimed at facilitating patient adherence: 1) social norming; comparison of a patient to her or his peers, and 2) frequent monitoring of progress and outcomes. This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice. This study will use a single cohort, double-baseline design (n=30 older adults with vestibular hypofunction). Following, the baseline (control) phase, all participants will complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system. Preliminary efficacy of the intervention will be examined by comparing computerized Dynamic Visual Acuity (cDVA) scores during the intervention phase to cDVA scores during the baseline phase. Feasibility and safety of the intervention will be examined relative to a priori thresholds for recruitment, retention and adherence rates, as well as recording of adverse events. Finally, the acceptability and remote/telehealth capability of the system will be explored using a mixed methods analysis, which will inform system refinement in preparation for a future R01 submission (phase II clinical trial).
- Conditions
- Vestibular Hypofunction
- Being tested
- MINDGAPS
- Keywords
- Rehabilitation, dynamic visual acuity, gaze stability, postural stability, dizziness
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDGAPSBehavioural
Utilize wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises during a 6-week training period. Additionally, NIH Toolbox data will be used to display patient status compared to normative values and to indicate progress over time relative to measurement error.
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Dynamic Visual Acuity (cDVA)
computerized measure of functional gaze stability
Measured: through study completion, an average of 12 weeks
Secondary outcomes (6)
Instrumented postural sway assessment
instrumented assessment of static postural stability
Measured: through study completion, an average of 12 weeks
Video head impulse testing (vHIT)
computerized assessment of vestibulo-ocular reflex function
Measured: through study completion, an average of 12 weeks
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a 10-item measure that examines dynamic stability during various walking tasks on a marked 6-m (20-ft) length and 12-inch wide walkway. Each item is rated from 0-3 with higher scores indicating better dynamic stability. Tasks within the FGA require head and/or body motion during walking activities which will be assessed using body-worn 3D inertial measurement units.
Measured: through study completion, an average of 12 weeks
Activities-specific Balance Confidence Scale (ABC)
The Activity Specific Balance Confidence Scale (ABC) is a 16-item self-reported measure of balance confidence in performing various activities of daily living. Each question requires an individual to grade his or her self on a scale of 0 to 100 percent for their level of confidence and higher scores indicate greater balance confidence in performing these activities.
Measured: through study completion, an average of 12 weeks
Dizziness Handicap Inventory (DHI)
Dizziness Handicap Inventory (DHI): The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap.
Measured: through study completion, an average of 12 weeks
Mini- Balance Evaluation Systems Test (BESTest)
the 14-item Mini-BESTest which includes four sections (anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait) relevant to postural control and stability. The maximum possible score is 28 with higher scores indicating better balance. Tasks within the Mini-BEST test require head and/ or body motion, which will be assessed using body-worn 3D inertial measurement units.
Measured: through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start11 May 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular HypofunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-cohort double-baseline design
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Brian Loyd, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391932
- Sponsor's protocol ID
- IRB #10-22
- Other IDs
- R21DC020251
- Acronym
- MINDGAPS
- Status last verified
- Jul 2026
- First submitted
- 11 May 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making INformed Decisions in Gaze and Postural Stability (MINDGAPS): A Novel System for Improving Personalized Care and Patient Adherence in Vestibular Rehabilitation
- ClinicalTrials.gov ID
- NCT05391932
- Acronym / sponsor ID
- MINDGAPS / IRB #10-22
- Conditions
- Vestibular Hypofunction
- Keywords
- Rehabilitation, dynamic visual acuity, gaze stability, postural stability, dizziness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 May 2022 (actual)
- 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.
The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. In this investigation the investigators will: 1) assess the preliminary efficacy of a novel intervention system for improving vestibular function and dizziness in community-dwelling older adults, 2) assess the safety and feasibility of the this system, and 3) assess the acceptability and implementation potential of this system, prior to a large-scale, R01-level investigation.
Detailed description
Deficits in gaze and postural stability are closely linked with vestibular hypofunction. These deficits result in dizziness and poor balance, increasing the risk for falls and other poor health outcomes. Vestibular hypofunction occurs with several conditions and is increasingly prevalent with advancing age. An estimated 85% of people over the age of 80 experience vestibular hypofunction. As with many age-related health challenges (e.g. sarcopenia, osteoporosis, cardiovascular disease), exercise is widely recommended to remediate the effects of vestibular hypofunction. Vestibular rehabilitation has demonstrated efficacy at improving vestibular hypofunction in tightly controlled clinical trials, but the effectiveness in practice is limited by two major barriers: 1) reduced patient adherence to the exercise program, and 2) inability to precisely assess vestibular function. These are overlapping challenges; lack of access to vestibular function assessments impedes effective dosing of rehabilitation as well as monitoring of patient adherence and progress. Thus, personalization and monitoring-essential ingredients of nearly any health or exercise regimen-are functionally missing in vestibular rehabilitation practice.
For this proposal, the investigators have developed the Making INformed Decisions in Gaze and Postural Stability (MINDGAPS) system, which utilizes wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises. Additionally, MINDGAPS leverages NIH Toolbox data to display patient status compared to normative values and to indicate progress over time relative to measurement error. This enables the application of two innovative behavioral science principles aimed at facilitating patient adherence: 1) social norming; comparison of a patient to her or his peers, and 2) frequent monitoring of progress and outcomes. This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice. This study will use a single cohort, double-baseline design (n=30 older adults with vestibular hypofunction). Following, the baseline (control) phase, all participants will complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system. Preliminary efficacy of the intervention will be examined by comparing computerized Dynamic Visual Acuity (cDVA) scores during the intervention phase to cDVA scores during the baseline phase. Feasibility and safety of the intervention will be examined relative to a priori thresholds for recruitment, retention and adherence rates, as well as recording of adverse events. Finally, the acceptability and remote/telehealth capability of the system will be explored using a mixed methods analysis, which will inform system refinement in preparation for a future R01 submission (phase II clinical trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single-cohort double-baseline design
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reports issues with dizziness or imbalance
- Ability to stand independently
- Presence of peripheral vestibular hypofunction as indicated by examination with video nystagmography, video head impulse testing, or dynamic visual acuity testing.
Key exclusion criteria (5 listed)
- cervical spine disorders
- vertebral or carotid artery dissection
- blindness
- peripheral or central oculomotor palsy
- centrally mediated vestibular dysfunction
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 |
|---|---|---|
| MINDGAPSUtilize wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises during a 6-week training period. Additionally, NIH Toolbox data will be used to display patient status compared to normative values and to indicate progress over time relative to measurement error. | Behavioural | – |
Primary outcome
Computerized Dynamic Visual Acuity (cDVA)
Time frame: through study completion, an average of 12 weeks
computerized measure of functional gaze stability
6 secondary outcomes
Instrumented postural sway assessment
Time frame: through study completion, an average of 12 weeks
Video head impulse testing (vHIT)
Time frame: through study completion, an average of 12 weeks
Functional Gait Assessment (FGA)
Time frame: through study completion, an average of 12 weeks
Activities-specific Balance Confidence Scale (ABC)
Time frame: through study completion, an average of 12 weeks
Dizziness Handicap Inventory (DHI)
Time frame: through study completion, an average of 12 weeks
Mini- Balance Evaluation Systems Test (BESTest)
Time frame: through study completion, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDGAPS in people with Vestibular Hypofunction, run by University of Montana 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian J Loyd, PhD (406-243-4015, Brian.loyd@umontana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized Dynamic Visual Acuity (cDVA) (time frame: through study completion, an average of 12 weeks). 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 Jul 2026.