Dawn Simulation and Postural Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632318
• Other study ID #: IRB-36269
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2019
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Device:
• Light
30 minutes of dawn simulation

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Palo Alto Veterans Institute for Research, Velux Fonden

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathovagal balance derived from blood pressure measurement	measure of sympathovagal balance derived from blood pressure measurement at wake time	30 minutes