Dawn Simulation and Postural Hypotension

October 24, 2019 updated by: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light
Dawn simulation for 30 minutes prior to habitual wake time
Device: Light
30 minutes of dawn simulation
No Intervention: No light
Darkness for 30 minutes prior to habitual wake time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sympathovagal balance derived from blood pressure measurement
Time Frame: 30 minutes
measure of sympathovagal balance derived from blood pressure measurement at wake time
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Collaborators

Palo Alto Veterans Institute for Research
Velux Fonden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-36269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data will be made available upon request following publication of summary data.

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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