Benign Paroxysmal Positional Vertigo in Older Adults

Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty

Despite the growing research on Benign Paroxysmal Positioning Vertigo (BPPV), the impact and treatment efficacy on balance, physical activity (and consequently) frailty in elderly is lacking. Also, the added value of the video Head Impulse Test (vHIT) in this population has never been studied before. With insights gained from this research, we hope to contribute to an efficient treatment of BPPV in this growing population and to minimize its impact and healthcare burden.

Study Overview

• Status: Recruiting
• Conditions: Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Other: Particle Repositioning Maneuver

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Pauwels, drs.; Phone Number: +32 11 26 88 55; Email: sara.pauwels@uhasselt.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Nele Lemkens, MD; Phone Number: +32 11 26 88 55; Email: Nele.lemkens@zol.be
    • Contact: Sara Pauwels, drs; Phone Number: +32 11 26 88 55; Email: sara.pauwels@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persons ≥ 65 years old
• Able to stand independent for at least 30 seconds
• Able to walk (with or without) walking aid for at least 10 meters
• Patients diagnosed with posterior semicircular canal BPPV
• Patients diagnosed with lateral-semicircular canal BPPV

Exclusion Criteria:

• Unable to understand and follow simple instructions (e.g. due to severe dementia, hearing loss or visual impairment)
• Persons temporarily or permanently living in a residential or psychiatric care centre, a home for the disabled or rehabilitation centre
• Persons with contra-indications for the diagnostic maneuver, vHIT or caloric irrigation test (e.g. severe limitation in mobility of the cervical spine of perforation of the tympanic membrane)
• Persons with other (acute) vestibular disorders and who as a result no longer meet the above mentioned diagnostic criteria for BPPV
• Persons with evolutionary disorders of the central nervous system (e.g. multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis).
• Persons who are already taking antivertigo drugs.
• Persons still in the rehabilitation phase after an orthopedic or cardiovascular incident.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Older adults with BPPV	Other: Particle Repositioning Maneuver; treatment with Particle Repositioning Maneuver
NO_INTERVENTION: Older adults without BPPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mini Balance Evalutation System test (miniBEStest)	The MiniBEStest is a 14-item test that measures 4 different balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Items are scored on a 3-level ordinal scale. The CTSIB is used to assess sensory contributions to postural control during 6 sensory conditions: stand on firm surface with eyes open, stand on foam surface with eyes open, stand on firm surface with visual conflict dome, stand on foam surface with visual conflict dome, stand on firm surface with eyes closed and stand on foam surface with eyes closed.	baseline
The mini Balance Evalutation System test (miniBEStest)	The MiniBEStest is a 14-item test that measures 4 different balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Items are scored on a 3-level ordinal scale. The CTSIB is used to assess sensory contributions to postural control during 6 sensory conditions: stand on firm surface with eyes open, stand on foam surface with eyes open, stand on firm surface with visual conflict dome, stand on foam surface with visual conflict dome, stand on firm surface with eyes closed and stand on foam surface with eyes closed.	month 1
The mini Balance Evalutation System test (miniBEStest)	The MiniBEStest is a 14-item test that measures 4 different balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Items are scored on a 3-level ordinal scale. The CTSIB is used to assess sensory contributions to postural control during 6 sensory conditions: stand on firm surface with eyes open, stand on foam surface with eyes open, stand on firm surface with visual conflict dome, stand on foam surface with visual conflict dome, stand on firm surface with eyes closed and stand on foam surface with eyes closed.	month 3
The mini Balance Evalutation System test (miniBEStest)	The MiniBEStest is a 14-item test that measures 4 different balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Items are scored on a 3-level ordinal scale. The CTSIB is used to assess sensory contributions to postural control during 6 sensory conditions: stand on firm surface with eyes open, stand on foam surface with eyes open, stand on firm surface with visual conflict dome, stand on foam surface with visual conflict dome, stand on firm surface with eyes closed and stand on foam surface with eyes closed.	month 6
10 meter walk test	During the 10 meter walk test the participant is instructed to walk 10 meter at his/her preferred walking speed. Gait parameters will be assessed.	Baseline
10 meter walk test	During the 10 meter walk test the participant is instructed to walk 10 meter at his/her preferred walking speed. Gait parameters will be assessed.	month 1
10 meter walk test	During the 10 meter walk test the participant is instructed to walk 10 meter at his/her preferred walking speed. Gait parameters will be assessed.	month 3
10 meter walk test	During the 10 meter walk test the participant is instructed to walk 10 meter at his/her preferred walking speed. Gait parameters will be assessed.	month 6
physical activity level measurde by an accelerometer (MOX)	Objective measurement of physical activity level of four days will be done by an accelerometer (MOX), that measures time spent in certain positions. The accelerometer is attached to the upper leg of the participant.	baseline
physical activity level measurde by an accelerometer (MOX)	Objective measurement of physical activity level of four days will be done by an accelerometer (MOX), that measures time spent in certain positions. The accelerometer is attached to the upper leg of the participant.	month 1
physical activity level measurde by an accelerometer (MOX)	Objective measurement of physical activity level of four days will be done by an accelerometer (MOX), that measures time spent in certain positions. The accelerometer is attached to the upper leg of the participant.	month 3
physical activity level measurde by an accelerometer (MOX)	Objective measurement of physical activity level of four days will be done by an accelerometer (MOX), that measures time spent in certain positions. The accelerometer is attached to the upper leg of the participant.	month 6
The International Physical Activity Questionnaire	used to measure the level of physical activity by questionnaire. This questionnaire consists of 31 questions divided over 5 subcategories. A higher score means a higher level of physical activity.	Baseline
The International Physical Activity Questionnaire	used to measure the level of physical activity by questionnaire. This questionnaire consists of 31 questions divided over 5 subcategories. A higher score means a higher level of physical activity.	Month 1
The International Physical Activity Questionnaire	used to measure the level of physical activity by questionnaire. This questionnaire consists of 31 questions divided over 5 subcategories. A higher score means a higher level of physical activity.	Month 3
The International Physical Activity Questionnaire	used to measure the level of physical activity by questionnaire. This questionnaire consists of 31 questions divided over 5 subcategories. A higher score means a higher level of physical activity.	Month 6
Frailty	Frailty is defined as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (more than 3 kg during last year and/or BMI ≤ 21 kg/m2), weakness (unable to rise from a chair), self-reported exhaustion, slow walking speed (velocity on 10 meter walk test) and low physical activity (answering 'no' to the question 'do you perform regular physical activity as walking, gardening or sport).	baseline
Frailty	Frailty is defined as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (more than 3 kg during last year and/or BMI ≤ 21 kg/m2), weakness (unable to rise from a chair), self-reported exhaustion, slow walking speed (velocity on 10 meter walk test) and low physical activity (answering 'no' to the question 'do you perform regular physical activity as walking, gardening or sport).	month 1
Frailty	Frailty is defined as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (more than 3 kg during last year and/or BMI ≤ 21 kg/m2), weakness (unable to rise from a chair), self-reported exhaustion, slow walking speed (velocity on 10 meter walk test) and low physical activity (answering 'no' to the question 'do you perform regular physical activity as walking, gardening or sport).	month 3
Frailty	Frailty is defined as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (more than 3 kg during last year and/or BMI ≤ 21 kg/m2), weakness (unable to rise from a chair), self-reported exhaustion, slow walking speed (velocity on 10 meter walk test) and low physical activity (answering 'no' to the question 'do you perform regular physical activity as walking, gardening or sport).	month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Montreal Cognitive Assessment (MOCA)	Cognitive function of older adults with BPPV will be compared to cognitive function of older adults without BPPV. Cognitive function will be assessed with the Montreal Cognitive Assessment (MOCA). MOCA assesses short term memory, visuospatial abilities, executive functions, attention and working memory, language and orientation to time and place.	Baseline
the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	baseline
the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 1
the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 3
the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 6
Age	Years	Throug study completion, an average of 6 months
Height	meters	Throug study completion, an average of 6 months
BPPV-symptomatology		Throug study completion, an average of 6 months
medication use	medication use will be questioned	Throug study completion, an average of 6 months
Living situation	Living situation wil be questioned	Throug study completion, an average of 6 months
Walking aid	Walking aid wil be questioned	Throug study completion, an average of 6 months
Fall history	Fall History will be measured during the follow-up period by a 2-weekly telephone interview.	Up to the end of the study

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Study Chair: Sara Pauwels, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (ACTUAL): August 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: BPPVOA-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No