Benign Paroxysmal Positional VertigoNCT05013684
Benign Paroxysmal Positional Vertigo in Older Adults
A study testing Particle Repositioning Maneuver in people with Benign Paroxysmal Positional Vertigo, run by Hasselt University at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Particle Repositioning Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Nele Lemkens, MD, +32 11 26 88 55, Nele.lemkens@zol.be
Sara Pauwels, drs, +32 11 26 88 55, sara.pauwels@uhasselt.be
About this study
Official title: 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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Particle Repositioning Maneuver
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particle Repositioning ManeuverOther
treatment with Particle Repositioning Maneuver
| Study group | Role | What they receive |
|---|---|---|
| Older adults with BPPV | Active comparator | Not described Receives: Other: Particle Repositioning Maneuver |
| Older adults without BPPV | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: month 6
Secondary outcomes (12)
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.
Measured: Baseline
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Measured: baseline
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Measured: Month 1
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Measured: Month 3
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Measured: Month 6
Age
Years
Measured: Throug study completion, an average of 6 months
Height
meters
Measured: Throug study completion, an average of 6 months
BPPV-symptomatology
Measured: Throug study completion, an average of 6 months
medication use
medication use will be questioned
Measured: Throug study completion, an average of 6 months
Living situation
Living situation wil be questioned
Measured: Throug study completion, an average of 6 months
Walking aid
Walking aid wil be questioned
Measured: 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.
Measured: Up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start8 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, JSpildooren, Hasselt University
- Investigators
- Joke Spildooren, prof. dr., Principal investigator, Hasselt UniversitySara Pauwels, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013684
- Sponsor's protocol ID
- BPPVOA-001
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty
- ClinicalTrials.gov ID
- NCT05013684
- Acronym / sponsor ID
- BPPVOA-001
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Aug 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older adults with BPPV | Active comparator | Other: Particle Repositioning Maneuver |
| Older adults without BPPV | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| Particle Repositioning Maneuvertreatment with Particle Repositioning Maneuver | Other | Older adults with BPPV |
Primary outcome
The mini Balance Evalutation System test (miniBEStest)
Time frame: baseline
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.
The mini Balance Evalutation System test (miniBEStest)
Time frame: month 1
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.
The mini Balance Evalutation System test (miniBEStest)
Time frame: month 3
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.
The mini Balance Evalutation System test (miniBEStest)
Time frame: month 6
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.
10 meter walk test
Time frame: Baseline
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.
10 meter walk test
Time frame: month 1
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.
10 meter walk test
Time frame: month 3
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.
10 meter walk test
Time frame: month 6
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.
physical activity level measurde by an accelerometer (MOX)
Time frame: baseline
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.
physical activity level measurde by an accelerometer (MOX)
Time frame: month 1
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.
physical activity level measurde by an accelerometer (MOX)
Time frame: month 3
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.
physical activity level measurde by an accelerometer (MOX)
Time frame: month 6
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.
The International Physical Activity Questionnaire
Time frame: Baseline
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.
The International Physical Activity Questionnaire
Time frame: Month 1
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.
The International Physical Activity Questionnaire
Time frame: Month 3
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.
The International Physical Activity Questionnaire
Time frame: Month 6
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.
Frailty
Time frame: baseline
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).
Frailty
Time frame: month 1
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).
Frailty
Time frame: month 3
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).
Frailty
Time frame: month 6
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).
12 secondary outcomes
the Montreal Cognitive Assessment (MOCA)
Time frame: Baseline
the 15-item Geriatric Depression Scale
Time frame: baseline
the 15-item Geriatric Depression Scale
Time frame: Month 1
the 15-item Geriatric Depression Scale
Time frame: Month 3
the 15-item Geriatric Depression Scale
Time frame: Month 6
Age
Time frame: Throug study completion, an average of 6 months
Height
Time frame: Throug study completion, an average of 6 months
BPPV-symptomatology
Time frame: Throug study completion, an average of 6 months
medication use
Time frame: Throug study completion, an average of 6 months
Living situation
Time frame: Throug study completion, an average of 6 months
Walking aid
Time frame: Throug study completion, an average of 6 months
Fall history
Time frame: Up to the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
Joke Spildooren, prof. dr. principal investigator
Hasselt University
Sara Pauwels, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particle Repositioning Maneuver in people with Benign Paroxysmal Positional Vertigo, run by Hasselt University at 1 site in Belgium.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joke Spildooren, prof. dr. (+3211269178, joke.spildooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mini Balance Evalutation System test (miniBEStest) (time frame: baseline). The study lists 20 primary outcomes in all. 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 19 Aug 2021.