- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712243
Light to Maximize Vision, Minimize Insomnia
November 1, 2016 updated by: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 55-85
- At least 20/200 corrected visual acuity
- Greater than 20° visual field with no lower visual field loss
- Stable health
- Male or female
- Normal color vision
- Normal hearing
Exclusion Criteria:
- Extreme chronotype
- Sleep disorders
- Dementia
- Smoker
- Depression
- Alcohol abuse
- Use of illegal drugs
- Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines)
- Use of light sensitizing drugs
- Self-reported history of nocturia (>3 times per night)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dim light
15 minutes of very dim (<1 lux) light during the night
|
|
Active Comparator: Room light
15 minutes of normal room light (~100 lux) during the night
|
|
Experimental: Colored light
15 minutes of colored light during the night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobile balance
Time Frame: 15 minutes
|
Mobile balance as determined using a GaitRite walkway
|
15 minutes
|
Alertness
Time Frame: 15 minutes
|
Alertness as determined by electroencephalographic power density
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
October 19, 2012
First Submitted That Met QC Criteria
October 19, 2012
First Posted (Estimate)
October 23, 2012
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1I21RX000773-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postural Balance
-
Baltimore VA Medical CenterCompleted
-
Escoles Universitaries GimbernatCompleted
-
East Tennessee State UniversityCompletedPostural BalanceUnited States
-
University of Rennes 2Completed
-
Carrick Institute for Graduate StudiesCompletedPostural BalanceUnited States, Australia
-
University of SalamancaCompleted
-
Foundation University IslamabadRecruitingProprioception, Postural BalancePakistan
-
Accademia Italiana Medicina OsteopaticaCompleted
-
University of Sao Paulo General HospitalCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.UnknownPostural BalanceBrazil
-
University of Sao PauloCompleted
Clinical Trials on Light
-
Icahn School of Medicine at Mount SinaiRecruitingMild Cognitive ImpairmentUnited States
-
China Medical University HospitalNot yet recruiting
-
University Hospital, Strasbourg, FranceRecruiting
-
Shanghai Zhongshan HospitalFudan University; Shanghai Mental Health Center, Jingan District; Shanghai Mental...Unknown
-
Matthew Neal MDTerminatedPancreatic Neoplasms | Rectal NeoplasmsUnited States
-
University of BaselHorizon 2020 - European CommissionNot yet recruitingLight FlashingSwitzerland
-
University of LiegeUnknown
-
University of CalgaryCanadian Cancer Society (CCS)Completed
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI); University of California, San Diego; Hackensack...CompletedQuality of Life | Breast Cancer | Fatigue | Sleep | Mild Cognitive Impairment | Hematopoietic Stem Cell Transplantation | LightUnited States
-
Stanford UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting