Dawn Simulation and Postural Hypotension

• Sponsor: VA Palo Alto Health Care System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02632318
• Collaborator: Velux Fonden (Other), Palo Alto Veterans Institute for Research (Other)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 29
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension	Device: Light	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 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
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sympathovagal balance derived from blood pressure measurement [30 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304

Sponsors and Collaborators

• VA Palo Alto Health Care System
• Velux Fonden
• Palo Alto Veterans Institute for Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
• ClinicalTrials.gov Identifier: NCT02632318
• Other Study ID Numbers: IRB-36269
• First Posted: Dec 16, 2015
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hypotension, Orthostatic; Hypotension

Study Results

No Results Posted as of Oct 25, 2019