Sleeplight-ageNCT02216318
Energy-efficient and Health Promoting Light for Elderly People
A study testing blue light in people with Sleep, run by Glostrup University Hospital, Copenhagen.
Trial summary
to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- blue light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2013
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 to 85 years
Who cannot join
- Conditions which will interfere by the primary endpoint as evaluated by the medical doctor
About this study
Official title: A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years
to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime
Read the detailed description
Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.
Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.
In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.
- Conditions
- Sleep
- Being tested
- blue light
- Keywords
- sleep, circadian, melatonine, pupil response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blue lightOther
| Study group | Role | What they receive |
|---|---|---|
| red light | Placebo comparator | red light during the whole day Receives: Other: blue light |
| Blue light | Active comparator | Blue light during early day Receives: Other: blue light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep length
The mean of sleep length during the last week of each light period
Measured: 1 week
Secondary outcomes (1)
actigraphy
mean sleep efficiency during the last week in each light period
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Elforsk, Albertslund Kommune, Gate 21, DTU Fotonik, VISO systems, AF Lightning, Philips Healthcare, Statens Byggeforskningsinstitut
- Responsible party
- Principal investigator, Line Kessel, Glostrup University Hospital, Copenhagen
- Investigators
- Line Kessel, MD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216318
- Sponsor's protocol ID
- H-3-2013-085
- Acronym
- light-age
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2014
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years
- ClinicalTrials.gov ID
- NCT02216318
- Acronym / sponsor ID
- light-age / H-3-2013-085
- Conditions
- Sleep
- Keywords
- sleep, circadian, melatonine, pupil response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Elforsk, Albertslund Kommune, Gate 21, DTU Fotonik, VISO systems, AF Lightning, Philips Healthcare, Statens Byggeforskningsinstitut
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Aug 2014 (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.
to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime
Detailed description
Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.
Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.
In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| red light | Placebo comparator | Other: blue lightred light during the whole day |
| Blue light | Active comparator | Other: blue lightBlue light during early day |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 65 to 85 years
Key exclusion criteria (1 listed)
- Conditions which will interfere by the primary endpoint as evaluated by the medical doctor
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 |
|---|---|---|
| blue light | Other | Blue light, red light |
Primary outcome
Sleep length
Time frame: 1 week
The mean of sleep length during the last week of each light period
1 secondary outcome
actigraphy
Time frame: 1 week
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 6 Aug 2018.
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Healthy Adult Participants
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.
Line Kessel, MD principal investigator
Glostrup University Hospital, Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing blue light in people with Sleep, run by Glostrup University Hospital, Copenhagen.
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 1 inclusion and 1 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Sleep length (time frame: 1 week). 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 6 Aug 2018.