Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia

NCT ID: NCT01350505

Last Updated: 2019-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-15

Study Completion Date

2017-06-30

Brief Summary

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To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.

Detailed Description

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Conditions

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Falls Balance Insomnia Aging

Study Design

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Intervention Model

CROSSOVER

The order of the interventions were randomized to the four visits.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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All subjects

13 minutes of light at night (2 hours after bedtime)

Group Type EXPERIMENTAL

White light exposure

Intervention Type BEHAVIORAL

\~200 lux of broad spectrum white light

Dim white light exposure

Intervention Type BEHAVIORAL

\~28 lux of broad spectrum white light

Very dim white light exposure

Intervention Type BEHAVIORAL

\<0.5 lux of broad spectrum white light

Dim orange light exposure

Intervention Type BEHAVIORAL

\~28 lux of orange light

Interventions

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White light exposure

\~200 lux of broad spectrum white light

Intervention Type BEHAVIORAL

Dim white light exposure

\~28 lux of broad spectrum white light

Intervention Type BEHAVIORAL

Very dim white light exposure

\<0.5 lux of broad spectrum white light

Intervention Type BEHAVIORAL

Dim orange light exposure

\~28 lux of orange light

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 55-85
* Stable health
* Normal color vision

Exclusion Criteria

* Alcohol abuse
* Depression
* Sleep disorders
* Smoking
* Use of illegal drugs
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie M Zeitzer, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

Countries

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United States

References

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McBean AL, Najjar RP, Schuchard RA, Hall CD, Wang CA, Ku B, Zeitzer JM. Standing Balance and Spatiotemporal Aspects of Gait Are Impaired Upon Nocturnal Awakening in Healthy Late Middle-Aged and Older Adults. J Clin Sleep Med. 2016 Nov 15;12(11):1477-1486. doi: 10.5664/jcsm.6270.

Reference Type RESULT
PMID: 27448415 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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E0773-P

Identifier Type: -

Identifier Source: org_study_id

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