FallsNCT01350505
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
A study testing White light exposure, Dim white light exposure and Very dim white light exposure in people with Falls and Balance, run by VA Office of Research and Development at 1 site in United States.
Trial summary
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- What is being tested?
- White light exposure, Dim white light exposure and Very dim white light exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2013to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Stable health
- Normal color vision
Who cannot join
- Alcohol abuse
- Depression
- Sleep disorders
- Smoking
- Use of illegal drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.
- Being tested
- White light exposure, Dim white light exposure, Very dim white light exposure, Dim orange light exposure
- Keywords
- Postural Balance, Sleep Initiation and Maintenance Disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White light exposureBehavioural
~200 lux of broad spectrum white light
Dim white light exposureBehavioural
~28 lux of broad spectrum white light
Very dim white light exposureBehavioural
<0.5 lux of broad spectrum white light
Dim orange light exposureBehavioural
~28 lux of orange light
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | 13 minutes of light at night (2 hours after bedtime) Receives: Behavioral: White light exposure; Behavioral: Dim white light exposure; Behavioral: Very dim white light exposure; Behavioral: Dim orange light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Balance
Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.
Measured: 13 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start15 Oct 2013
- Primary completion31 Jan 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Model description
- The order of the interventions were randomized to the four visits.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jamie M Zeitzer, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350505
- Sponsor's protocol ID
- E0773-P
- Status last verified
- Sep 2018
- First submitted
- 6 May 2011
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All relevant summary data is presented in a publication under review. Anonymized, individual participant data would be made available upon request and completion of necessary documentation.
Publications
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.
PubMed 27448415
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. 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
- NCT01350505
- Acronym / sponsor ID
- E0773-P
- Keywords
- Postural Balance, Sleep Initiation and Maintenance Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
- Model description
- The order of the interventions were randomized to the four visits.
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Behavioral: White light exposure, Behavioral: Dim white light exposure, Behavioral: Very dim white light exposure, Behavioral: Dim orange light exposure13 minutes of light at night (2 hours after bedtime) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 55-85
- Stable health
- Normal color vision
Key exclusion criteria (5 listed)
- Alcohol abuse
- Depression
- Sleep disorders
- Smoking
- Use of illegal drugs
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 |
|---|---|---|
| White light exposure~200 lux of broad spectrum white light | Behavioural | All subjects |
| Dim white light exposure~28 lux of broad spectrum white light | Behavioural | All subjects |
| Very dim white light exposure<0.5 lux of broad spectrum white light | Behavioural | All subjects |
| Dim orange light exposure~28 lux of orange light | Behavioural | All subjects |
Primary outcome
Change in Balance
Time frame: 13 minutes
Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27448415McBean 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.
- Individual participant dataSharing planned: Yes. All relevant summary data is presented in a publication under review. Anonymized, individual participant data would be made available upon request and completion of necessary documentation.
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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.
Jamie M Zeitzer, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White light exposure, Dim white light exposure and Very dim white light exposure in people with Falls and Balance, run by VA Office of Research and Development 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 3 inclusion and 5 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 15 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Balance (time frame: 13 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350505, which also lists 1 linked publication.
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 15 Feb 2019.