Orthostatic; Hypotension, NeurogenicNCT04782830
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
A study testing Accelerometer and Midodrine or atomoxetine pill in people with Orthostatic; Hypotension, Neurogenic and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Orthostatic; Hypotension, Neurogenic, Autonomic Failure, Pure Autonomic Failure
- What is being tested?
- Accelerometer and Midodrine or atomoxetine pill
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 1 Oct 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, age 40-80 years.
- Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.
- Neurogenic orthostatic hypotension defined as a ≥ 30 mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- Patients on treatment for neurogenic orthostatic hypotension with either midodrine or atomoxetine, who have experienced some improvement in their orthostatic symptoms, but still remain symptomatic (Orthostatic hypotension symptom assessment [OHSA] score of 1 to 5 while on medication).
- Patients who are able to stay with their caregiver during study participation.
- Able and willing to provide informed consent.
Who cannot join
- Bedridden, physically disabled, or unable to walk.
- Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment.
- Patients taking more than one medication for the treatment of neurogenic orthostatic hypotension (concomitant use of pyridostigmine or fludrocortisone are accepted).
- Pregnancy
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke).
- Concomitant use of anticoagulants.
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
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Emily C Smith, RN MPH, 615.875.1516, autonomics@vumc.org
Bonnie K Black, RN, 615-322-3304, autonomics@vumc.org
About this study
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses). Total upright time (i.e. tolerance to standing and walking) will be compared between placebo and active treatment to test the hypothesis that it can be used to assess the efficacy of the treatment for orthostatic hypotension and whether this outcome is superior to the assessment of symptoms using validated questionnaires.
Read the detailed description
Patients with autonomic failure cannot regulate blood pressure properly. Upon standing, their blood pressure drops (i.e. orthostatic hypotension) and may cause symptoms such as lightheadedness, dizziness, changes in vision, weakness, fatigue, trouble concentrating, and shoulder and neck pain. Orthostatic hypotension can be severe and disabling; it can lead to frequent loss of consciousness and falls. These symptoms can make it difficult to perform activities of daily living resulting in significant impairment of the patient's quality of life. Thus, the assessment of orthostatic symptoms using validated questionnaires has been one of the main tools to determine the efficacy of treatment approaches for orthostatic hypotension. However, its usefulness may be limited by several factors including difficulty in the categorization of symptoms and rating of their severity, particularly in patients with some degree of cognitive impairment; the confounding effect of factors not related to orthostatic hypotension on patient's symptoms; difficulty in performing an accurate comparison of the severity of symptoms before and after treatment or between treatments; underestimating symptom burden by not reporting symptoms that are not included in the validated questionnaires or by problems in the patient recall.
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. The main hypothesis is that the quantification of upright time (standing and walking) with an activity monitor would be useful in the assessment of the severity of neurogenic orthostatic hypotension and the efficacy of the treatment for this condition and whether it would be superior to the assessment of symptoms using validated questionnaires.
Patients with autonomic failure and neurogenic orthostatic hypotension on treatment with either midodrine or atomoxetine will be eligible for this study. The study will take place at the participant's home with the assistance of his or her caregiver and frequent oversight from the investigative team. Participants will be studied for two separate weeks, one week with placebo and one week with their regular treatment (midodrine or atomoxetine at their usual doses), with one week in between for washout (the period of using participants' usual medication without any study measurement performed). The order of the study weeks with placebo or regular treatment will be randomized and the study medications will be blinded. On each study week, participants will be asked to wear an activity monitor (Activpal) on one of their thighs to measure the amount of time they spend in the upright posture (walking and standing), number of steps, activity and other characteristics related to the quantity and quality of walking and standing. Participants will be guided to write down the times of their daily activities, such as waking, sleeping, eating, and taking medication. At the end of each study week, the participants will be guided to fill out some questionnaires, and to take blood pressure measurements while lying down, sitting, and standing.
- Conditions
- Orthostatic; Hypotension, Neurogenic, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Orthostatic; Hypotension, Parkinsonism
- Being tested
- Accelerometer, placebo pill, Midodrine or atomoxetine pill
- Keywords
- orthostatic hypotension, autonomic failure, accelerometer, orthostatic symptoms
- Medical subject headings
- Hypotension, Pure Autonomic Failure, Multiple System Atrophy, Parkinsonian Disorders, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Also called ActivpalTM
A uniaxial accelerometer-based activity monitor (ActivpalTM) will be worn by participants on one of the thighs during the 7 days of the placebo and treatment periods.
placebo pillDrug
Also called sugar pill
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
Midodrine or atomoxetine pillDrug
Either midodrine or atomoxetine at their regular dose.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Experimental | Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine. Receives: Device: Accelerometer; Drug: placebo pill |
| Standard treatment | Active comparator | Either midodrine or atomoxetine at their regular dose. Receives: Device: Accelerometer; Drug: Midodrine or atomoxetine pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total standing time measured by an accelerometer
The percentage of total standing time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent in the upright and seated or supine positions.
Measured: 7 days of the treatment or placebo period
Orthostatic symptoms
Orthostatic symptoms measured by the Orthostatic Hypotension Questionnaire (OHQ). The questionnaire is divided into two parts: Part I, Symptom Assessment (OHSA), consisted of six questions, each rating the intensity of one characteristic symptom of OH: 1) Dizziness, lightheadedness, feeling faint, or feeling like you might blackout; 2) Blurring, seeing spots or tunnel vision; 3) Generalized weakness; 4) Fatigue; 5) Trouble concentrating; 6) Head/neck discomfort; and Part II, Daily Activity Scale (OHDAS), consisted of four questions that assessed the impact of neurogenic OH symptoms on daily activities. The recall period is ''over the past week''. The items are scored on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference, and the option of selecting ''cannot be done for other reasons''. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.
Measured: 7 days of treatment or placebo period
Secondary outcomes (2)
Total number of steps measured by an accelerometer
Number of steps during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs
Measured: 7 days of treatment or placebo period
Total walking time measured by an accelerometer
Total walking time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent walking, standing still, and sitting or lying down.
Measured: 7 days of treatment or placebo period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start5 Feb 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic; Hypotension, NeurogenicStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- placebo-controlled, double-blind, randomized crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University Medical Center
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782830
- Sponsor's protocol ID
- 201219
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2021
- Last updated
- 2 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
- ClinicalTrials.gov ID
- NCT04782830
- Acronym / sponsor ID
- 201219
- Conditions
- Orthostatic; Hypotension, Neurogenic, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Orthostatic; Hypotension, Parkinsonism
- Keywords
- orthostatic hypotension, autonomic failure, accelerometer, orthostatic symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Mar 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.
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses). Total upright time (i.e. tolerance to standing and walking) will be compared between placebo and active treatment to test the hypothesis that it can be used to assess the efficacy of the treatment for orthostatic hypotension and whether this outcome is superior to the assessment of symptoms using validated questionnaires.
Detailed description
Patients with autonomic failure cannot regulate blood pressure properly. Upon standing, their blood pressure drops (i.e. orthostatic hypotension) and may cause symptoms such as lightheadedness, dizziness, changes in vision, weakness, fatigue, trouble concentrating, and shoulder and neck pain. Orthostatic hypotension can be severe and disabling; it can lead to frequent loss of consciousness and falls. These symptoms can make it difficult to perform activities of daily living resulting in significant impairment of the patient's quality of life. Thus, the assessment of orthostatic symptoms using validated questionnaires has been one of the main tools to determine the efficacy of treatment approaches for orthostatic hypotension. However, its usefulness may be limited by several factors including difficulty in the categorization of symptoms and rating of their severity, particularly in patients with some degree of cognitive impairment; the confounding effect of factors not related to orthostatic hypotension on patient's symptoms; difficulty in performing an accurate comparison of the severity of symptoms before and after treatment or between treatments; underestimating symptom burden by not reporting symptoms that are not included in the validated questionnaires or by problems in the patient recall.
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. The main hypothesis is that the quantification of upright time (standing and walking) with an activity monitor would be useful in the assessment of the severity of neurogenic orthostatic hypotension and the efficacy of the treatment for this condition and whether it would be superior to the assessment of symptoms using validated questionnaires.
Patients with autonomic failure and neurogenic orthostatic hypotension on treatment with either midodrine or atomoxetine will be eligible for this study. The study will take place at the participant's home with the assistance of his or her caregiver and frequent oversight from the investigative team. Participants will be studied for two separate weeks, one week with placebo and one week with their regular treatment (midodrine or atomoxetine at their usual doses), with one week in between for washout (the period of using participants' usual medication without any study measurement performed). The order of the study weeks with placebo or regular treatment will be randomized and the study medications will be blinded. On each study week, participants will be asked to wear an activity monitor (Activpal) on one of their thighs to measure the amount of time they spend in the upright posture (walking and standing), number of steps, activity and other characteristics related to the quantity and quality of walking and standing. Participants will be guided to write down the times of their daily activities, such as waking, sleeping, eating, and taking medication. At the end of each study week, the participants will be guided to fill out some questionnaires, and to take blood pressure measurements while lying down, sitting, and standing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, double-blind, randomized crossover
| Arm | Type | Receives |
|---|---|---|
| placebo | Experimental | Device: Accelerometer, Drug: placebo pillPlacebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine. |
| Standard treatment | Active comparator | Device: Accelerometer, Drug: Midodrine or atomoxetine pillEither midodrine or atomoxetine at their regular dose. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects, age 40-80 years.
- Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.
- Neurogenic orthostatic hypotension defined as a ≥ 30 mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
- Patients on treatment for neurogenic orthostatic hypotension with either midodrine or atomoxetine, who have experienced some improvement in their orthostatic symptoms, but still remain symptomatic (Orthostatic hypotension symptom assessment [OHSA] score of 1 to 5 while on medication).
- Patients who are able to stay with their caregiver during study participation.
Key exclusion criteria (7 listed)
- Bedridden, physically disabled, or unable to walk.
- Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment.
- Patients taking more than one medication for the treatment of neurogenic orthostatic hypotension (concomitant use of pyridostigmine or fludrocortisone are accepted).
- Pregnancy
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
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 |
|---|---|---|
| AccelerometerAlso: ActivpalTMA uniaxial accelerometer-based activity monitor (ActivpalTM) will be worn by participants on one of the thighs during the 7 days of the placebo and treatment periods. | Device | Standard treatment, placebo |
| placebo pillAlso: sugar pillPlacebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine. | Drug | placebo |
| Midodrine or atomoxetine pillEither midodrine or atomoxetine at their regular dose. | Drug | Standard treatment |
Primary outcome
Total standing time measured by an accelerometer
Time frame: 7 days of the treatment or placebo period
The percentage of total standing time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent in the upright and seated or supine positions.
Orthostatic symptoms
Time frame: 7 days of treatment or placebo period
Orthostatic symptoms measured by the Orthostatic Hypotension Questionnaire (OHQ). The questionnaire is divided into two parts: Part I, Symptom Assessment (OHSA), consisted of six questions, each rating the intensity of one characteristic symptom of OH: 1) Dizziness, lightheadedness, feeling faint, or feeling like you might blackout; 2) Blurring, seeing spots or tunnel vision; 3) Generalized weakness; 4) Fatigue; 5) Trouble concentrating; 6) Head/neck discomfort; and Part II, Daily Activity Scale (OHDAS), consisted of four questions that assessed the impact of neurogenic OH symptoms on daily activities. The recall period is ''over the past week''. The items are scored on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference, and the option of selecting ''cannot be done for other reasons''. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.
2 secondary outcomes
Total number of steps measured by an accelerometer
Time frame: 7 days of treatment or placebo period
Total walking time measured by an accelerometer
Time frame: 7 days of treatment or placebo period
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 2 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.
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer and Midodrine or atomoxetine pill in people with Orthostatic; Hypotension, Neurogenic and Autonomic Failure, run by Vanderbilt University Medical Center 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 6 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: looking for participants now, as of the sponsor's last update on 2 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 Bonnie K Black, RN (615-343-6862, autonomics@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total standing time measured by an accelerometer (time frame: 7 days of the treatment or placebo period). The study lists 2 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 2 Jul 2026.