Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04782830
Status
Recruiting
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Conditions

  • Autonomic Failure
  • Multiple System Atrophy
  • Orthostatic; Hypotension, Neurogenic
  • Orthostatic; Hypotension, Parkinsonism
  • Pure Autonomic Failure

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Accelerometer — DEVICE
    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 pill — DRUG
    Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
  • Midodrine or atomoxetine pill — DRUG
    Either midodrine or atomoxetine at their regular dose.

Study Details

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.

Key Dates

Start date
Feb 5, 2021
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
29 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: placebo
    Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
  • Active Comparator: Standard treatment
    Either midodrine or atomoxetine at their regular dose.

Primary Outcome Measure

Total standing time measured by an accelerometer [ Time Frame: 7 days of the treatment or placebo period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashvilleTennessee37232
Emily C Smith, RN MPH
[email protected]
615.875.1516
Bonnie K Black, RN
[email protected]
615-322-3304
Jinwoo Park, MD (SUB_INVESTIGATOR)
Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR)
Luis E Okamoto, MD (SUB_INVESTIGATOR)
Alfredo Gamboa, MD (SUB_INVESTIGATOR)
Cyndya A Shibao, MD (SUB_INVESTIGATOR)
Andre Diedrich, MD, PhD (SUB_INVESTIGATOR)
Bonnie K Black, RN (SUB_INVESTIGATOR)
Emily C Smith, RN, MPH (SUB_INVESTIGATOR)

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By research site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center· Nashville, TN

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