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Dawn Simulation and Postural Hypotension

V

VA Palo Alto Health Care System

Status and phase

Completed
Phase 4

Conditions

Orthostatic Hypotension

Treatments

Device: Light

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02632318
IRB-36269

Details and patient eligibility

About

One of the most physiologically demanding things that older people do every day is to get up in the morning. After spending a night laying flat, where the blood distributes evenly across the body, when they stand in the morning (and the blood rushes to their feet), their cardiovascular system may not be able to compensate and maintain blood flow to the brain. This phenomenon is known as orthostatic or postural hypotension. The investigators have found in a group of young individuals that use of a dawn-simulation light that gradually wakes the brain is able to increase cardiovascular tone prior to arising. The goal of this experiment is to determine whether this dawn simulation light is able to increase cardiovascular tone in older adults such that they would have reduced or absent postural hypotension when they awaken in the morning. This would greatly reduce the risks of falls and their associated morbidities in older adults.

Enrollment

35 patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • History of falls or dizziness at exit from bed in the morning (at least two incidents in the past year)
  • At least 20/200 corrected visual acuity
  • Stable health
  • Normal hearing

Exclusion criteria

  • Regular cigarette smoker
  • Alcohol abuse
  • Drug abuse

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

35 participants in 2 patient groups

Light
Experimental group
Description:
Dawn simulation for 30 minutes prior to habitual wake time
Treatment:
Device: Light
No light
No Intervention group
Description:
Darkness for 30 minutes prior to habitual wake time

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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