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Dawn Simulation and Postural Hypotension

Primary Purpose

Orthostatic Hypotension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Light
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Orthostatic Hypotension

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Light

No light

Arm Description

Dawn simulation for 30 minutes prior to habitual wake time

Darkness for 30 minutes prior to habitual wake time

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 14, 2015
Last Updated
October 24, 2019
Sponsor
VA Palo Alto Health Care System
Collaborators
Velux Fonden, Palo Alto Veterans Institute for Research
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1. Study Identification

Unique Protocol Identification Number
NCT02632318
Brief Title
Dawn Simulation and Postural Hypotension
Official Title
Dawn Simulation as a Passive Countermeasure to Postural Hypotension in Healthy Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Velux Fonden, Palo Alto Veterans Institute for Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light
Arm Type
Experimental
Arm Description
Dawn simulation for 30 minutes prior to habitual wake time
Arm Title
No light
Arm Type
No Intervention
Arm Description
Darkness for 30 minutes prior to habitual wake time
Intervention Type
Device
Intervention Name(s)
Light
Intervention Description
30 minutes of dawn simulation
Primary Outcome Measure Information:
Title
Sympathovagal balance derived from blood pressure measurement
Description
measure of sympathovagal balance derived from blood pressure measurement at wake time
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual participant data will be made available upon request following publication of summary data.
Citations:
PubMed Identifier
32307533
Citation
Gabel V, Miglis M, Zeitzer JM. Effect of artificial dawn light on cardiovascular function, alertness, and balance in middle-aged and older adults. Sleep. 2020 Oct 13;43(10):zsaa082. doi: 10.1093/sleep/zsaa082.
Results Reference
derived

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Dawn Simulation and Postural Hypotension

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