Dawn Simulation and Postural Hypotension

NCT ID: NCT02632318

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Orthostatic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Light

Dawn simulation for 30 minutes prior to habitual wake time

Group Type EXPERIMENTAL

Light

Intervention Type DEVICE

30 minutes of dawn simulation

No light

Darkness for 30 minutes prior to habitual wake time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Light

30 minutes of dawn simulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Velux Fonden

OTHER

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Jamie M. Zeitzer, Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32307533 (View on PubMed)

Other Identifiers

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IRB-36269

Identifier Type: -

Identifier Source: org_study_id

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