- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782830
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bonnie K Black, RN
- Phone Number: 615-343-6862
- Email: autonomics@vumc.org
Study Locations
-
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Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Autonomic Dysfunction Center/ Vanderbilt University Medical Center
-
Contact:
- Bonnie K Black, RN
- Phone Number: 615-322-3304
- Email: autonomics@vumc.org
-
Sub-Investigator:
- Bonnie K Black, RN
-
Sub-Investigator:
- Luis E Okamoto, MD
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Principal Investigator:
- Italo Biaggioni, MD
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Sub-Investigator:
- Alfredo Gamboa, MD
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Sub-Investigator:
- Cyndya A Shibao, MD
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Sub-Investigator:
- Andre Diedrich, MD, PhD
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Contact:
- Emily C Smith, RN MPH
- Phone Number: 615-875-1516
- Email: autonomics@vumc.org
-
Sub-Investigator:
- Jinwoo Park, MD
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Sub-Investigator:
- Emily C Smith, RN, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: placebo
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
|
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.
Other Names:
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
Other Names:
|
Active Comparator: Standard treatment
Either midodrine or atomoxetine at their regular dose.
|
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.
Other Names:
Either midodrine or atomoxetine at their regular dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days of the treatment or placebo period
|
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.
|
7 days of treatment or placebo period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of steps measured by an accelerometer
Time Frame: 7 days of treatment or placebo period
|
Number of steps during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs
|
7 days of treatment or placebo period
|
Total walking time measured by an accelerometer
Time Frame: 7 days of treatment or placebo period
|
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.
|
7 days of treatment or placebo period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Hypotension
- Multiple System Atrophy
- Shy-Drager Syndrome
- Parkinsonian Disorders
- Hypotension, Orthostatic
- Pure Autonomic Failure
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Vasoconstrictor Agents
- Adrenergic alpha-1 Receptor Agonists
- Atomoxetine Hydrochloride
- Midodrine
Other Study ID Numbers
- 201219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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