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Dawn Simulation and Postural Hypotension

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ClinicalTrials.gov Identifier: NCT02632318
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Velux Fonden
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Device: Light Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dawn Simulation as a Passive Countermeasure to Postural Hypotension in Healthy Older Adults
Study Start Date : September 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Sympathovagal balance derived from blood pressure measurement [ Time Frame: 30 minutes ]
    measure of sympathovagal balance derived from blood pressure measurement at wake time



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632318


Contacts
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Contact: Yvonne Quevedo 650-493-5000 ext 61971 pavasleepstudy@gmail.com

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Virginie Gabel, PhD    650-493-5000    vgabel@stanford.edu   
Sponsors and Collaborators
VA Palo Alto Health Care System
Velux Fonden
Palo Alto Veterans Institute for Research

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Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02632318     History of Changes
Other Study ID Numbers: IRB-36269
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data will be made available upon request following publication of summary data.

Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases