Postural BalanceNCT01712243
Light to Maximize Vision, Minimize Insomnia
A study testing Light in people with Postural Balance, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Extreme chronotype
- Sleep disorders
- Dementia
- Smoker
- Depression
- Alcohol abuse
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Postural Balance
- Being tested
- Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightOther
| Study group | Role | What they receive |
|---|---|---|
| Dim light | Active comparator | 15 minutes of very dim (<1 lux) light during the night Receives: Other: Light |
| Room light | Active comparator | 15 minutes of normal room light (~100 lux) during the night Receives: Other: Light |
| Colored light | Experimental | 15 minutes of colored light during the night Receives: Other: Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile balance
Mobile balance as determined using a GaitRite walkway
Measured: 15 minutes
Alertness
Alertness as determined by electroencephalographic power density
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712243
- Sponsor's protocol ID
- 1I21RX000773-01A2
- Status last verified
- Nov 2016
- First submitted
- 19 Oct 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
- ClinicalTrials.gov ID
- NCT01712243
- Acronym / sponsor ID
- 1I21RX000773-01A2
- Conditions
- Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- Stanford University
- Study start
- Dec 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dim light | Active comparator | Other: Light15 minutes of very dim (<1 lux) light during the night |
| Room light | Active comparator | Other: Light15 minutes of normal room light (~100 lux) during the night |
| Colored light | Experimental | Other: Light15 minutes of colored light during the night |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Extreme chronotype
- Sleep disorders
- Dementia
- Smoker
- Depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light | Other | Colored light, Dim light, Room light |
Primary outcome
Mobile balance
Time frame: 15 minutes
Mobile balance as determined using a GaitRite walkway
Alertness
Time frame: 15 minutes
Alertness as determined by electroencephalographic power density
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light in people with Postural Balance, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile balance (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.