Making INformed Decisions in Gaze and Postural Stability: A Pilot Feasibility Study

NCT ID: NCT05391932

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2025-03-31

Brief 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. 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).

Conditions

Vestibular Hypofunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MINDGAPS

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• cervical spine disorders
• vertebral or carotid artery dissection
• blindness
• peripheral or central oculomotor palsy
• centrally mediated vestibular dysfunction

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Montana

OTHER

Sponsor Role: lead

Responsible Party

Brian Loyd

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Montana

Missoula, Montana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian J Loyd, PhD

Role: CONTACT

Brian.loyd@umontana.edu

406-243-4015

Andy Kittelson, PhD

Role: CONTACT

Andy.kittelson@umontana.edu

406-243-4015

Facility Contacts

Brian Loyd, PhD

Role: primary

Brian.loyd@umontana.edu

406-243-4015

Andy Kittelson, PhD

Role: backup

Andy.kittelson@umontana.edu

406-243-4015

Other Identifiers

R21DC020251

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB #10-22

Identifier Type: -

Identifier Source: org_study_id