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OpenTrials
Completed

NCT Number: NCT02632318

Dawn Simulation and Postural Hypotension

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.

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Key information

Conditions

Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Light

Device

30 minutes of dawn simulation

Primary outcomes

  1. Sympathovagal balance derived from blood pressure measurement

    Time frame: 30 minutes

    measure of sympathovagal balance derived from blood pressure measurement at wake time

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • Palo Alto Veterans Institute for Research
  • Velux Fonden

Registry information

Official study title

Dawn Simulation as a Passive Countermeasure to Postural Hypotension in Healthy Older Adults

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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