Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04502225
Status
Recruiting
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Conditions

  • Autonomic Failure
  • Supine Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Tilt — OTHER
    Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
  • Elevated trunk — OTHER
    Elevation of the trunk through raising just the head of the bed until the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
  • Tilt - In home — OTHER
    Tilt of the whole bed so that the head is elevated by 8 inches overnight.
  • Elevated Trunk - In home — OTHER
    Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.

Study Details

Many persons with autonomic failure often have high blood pressure when lying down (supine hypertension). This study is exploring the impact of decreased venous return to the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If decreased venous return to the heart is effective at lowering supine blood pressure, these approaches may be utilized to treat supine hypertension non-pharmacologically. Raising the head of the bed decreases the amount of blood returning to the heart due to the effects of gravity. In this case, the decreased blood return to the heart may decrease blood pressure.

Key Dates

Start date
Aug 21, 2020
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Elevation of the whole bed (tilt)
    Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.
  • Experimental: Elevation of the trunk
    Elevation of the trunk by tilting just the head of the bed so that the participant's head is raised by 9 and/or 12 inches.
  • Experimental: Elevation of the whole bed (tilt) - In home
    Tilt of the whole bed so that the participant's head is raised by 8 inches.
  • Experimental: Elevation of the trunk - In home
    Elevation of the trunk by raising the head 8 inches on a wedge pillow.

Primary Outcome Measure

Systolic Blood Pressure [ Time Frame: 10 PM to 8 AM ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Emily C Smith, RN BSN MPH
6158751516

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By research site
Vanderbilt University Medical Center· Nashville, TN

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