Dawn Simulation and Postural Hypotension

NCT02632318 | Completed Phase 4

• 1 other identifier: IRB-36269
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Sympathovagal balance derived from blood pressure measurement

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

  30 minutes

Study Arms (2)

Light

EXPERIMENTAL

Dawn simulation for 30 minutes prior to habitual wake time

Device: Light

No light

NO INTERVENTION

Darkness for 30 minutes prior to habitual wake time

Interventions

Light DEVICE

30 minutes of dawn simulation

Light

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Regular cigarette smoker
• Alcohol abuse
• Drug abuse

Sponsors & Collaborators

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

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 32307533 DERIVED

MeSH Terms

Conditions

Hypotension, Orthostatic

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: September 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)