Dawn Simulation and Postural Hypotension
Primary Purpose
Orthostatic Hypotension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Light
Sponsored by
About this trial
This is an interventional basic science trial for Orthostatic Hypotension
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
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
NCT ID
NCT02632318
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
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
Learn more about this trial
Dawn Simulation and Postural Hypotension
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