Non-visual PhotoreceptionNCT01586039
Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep
A study testing Visible light in people with Non-visual Photoreception, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-visual Photoreception
- What is being tested?
- Visible light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2014
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-30 years to reduce the confounding effects of lens aging on the transmission of light to the retina;
- Non-smoking for at least 6 months;
- Healthy (no medical, psychiatric or sleep disorders);
- No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, urine chemistry and ECG;
- Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative urine pregnancy test;
- Body mass index of > 18 or < 30 kg/m2;
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- No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
- Habitual caffeine consumption < 300mg per day on average;
- Habitual alcohol consumption < 10 alcoholic units per week on average.
Who cannot join
- History of alcohol or substance abuse;
- Positive result on drugs of abuse screening;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
- Psychiatric disorder;
- Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
- Visual disorder, including but not limited to color blindness, or family history of glaucoma;
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- History of intolerance or hypersensitivity to melatonin or melatonin agonists;
- Pregnancy or lactation;
- Shift work;
- Transmeridian travel (2 or more time zones) in past 2 months;
- Any other reason as determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep.
The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue light in the evening persist for at least 3-4 hours after the lights are turned off, and can disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep on subsequent sleep would be beneficial to sleep quality and potentially health.
The investigators will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). In a within-subject design, the investigators will test the hypotheses that exposure to a blue-depleted LED as compared to a CFL exposure at (1) 90 lux or (2) 50 lux will cause significantly:
- Less melatonin suppression between melatonin onset and bedtime;
- Less subjective and objective alerting responses before bedtime;
- Less disruption of nocturnal sleep structure and quality.
- Conditions
- Non-visual Photoreception
- Being tested
- Visible light
- Keywords
- Melatonin, Sleep, Light, Alertness, Circadian Rhythms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visible lightDevice
We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
| Study group | Role | What they receive |
|---|---|---|
| Compact Fluorescent Light 90 lux | Active comparator | 90 lux exposure of a commercially available Compact Fluorescent Light (CFL). Receives: Device: Visible light |
| Blue-depleted LED light 90 lux | Experimental | 90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). Receives: Device: Visible light |
| Compact Fluorescent Light 50 lux | Active comparator | 50 lux exposure of a commercially available Compact Fluorescent Light (CFL). Receives: Device: Visible light |
| Blue-depleted LED light 50 lux | Experimental | 50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). Receives: Device: Visible light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin Suppression
Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. AUC was calculated during the 6 h of light exposure and the corresponding 6-h interval 24 hours earlier. Higher values indicate more light-induced melatonin suppression.
Measured: 6-h constant posture interval of the light exposure
Secondary outcomes (4)
Sleep Structure
Sleep efficiency assessed by polysomnography. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a person spends in bed trying to sleep. The percentage is calculated by dividing the Total Sleep Time by the Total Time in Bed.
Measured: 8-h time in bed immediately following CFL/LED light exposure.
Sleep Quality
Self-reported sleep quality was assessed using a post sleep questionnaire. Score on subjective scale range 1-7, higher scores indicate higher sleep quality.
Measured: First morning after 8-h time in bed immediately following CFL/LED light exposure.
Subjective Alerting Response
Self-reported sleepiness measured during the light exposure using the Karolinska Sleepiness Scale (KSS). Range of scores 1-9, higher score indicate higher subjective sleepiness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
Measured: 6-h constant posture interval of the light exposure.
Objective Alerting Response
Mean reaction time assessed using the 10-minute psychomotor vigilance test. Higher numbers indicate slower reaction times indicating less alertness. Measures were taken hourly throughout the 6-hour constant posture interval of the light exposure and then averaged to calculate a single value per participant.
Measured: 6-h constant posture interval of the light exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
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.
- Other trials for Non-visual PhotoreceptionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Stratified randomized crossover trial. Participants randomized between CFL and LED conditions stratified by light intensity (50 lux and 90 lux).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biological Illumination, LLC
- Responsible party
- Principal investigator, Steven W. Lockley, Brigham and Women's Hospital
- Investigators
- Steven W Lockley, Ph.D., Principal investigator, Brigham and Women's Hospital; Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586039
- Sponsor's protocol ID
- 2011-P-002834
- Status last verified
- Sep 2021
- First submitted
- 24 Apr 2012
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep.
- ClinicalTrials.gov ID
- NCT01586039
- Acronym / sponsor ID
- 2011-P-002834
- Conditions
- Non-visual Photoreception
- Keywords
- Melatonin, Sleep, Light, Alertness, Circadian Rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Biological Illumination, LLC
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 5 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The timing and quality of sleep is governed by environmental and physiologic factors. Environmental factors, especially ambient lighting can impact the circadian system and alter the timing and structure of sleep. Light exposure can also acutely alter neural activation state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue light in the evening persist for at least 3-4 hours after the lights are turned off, and can disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep on subsequent sleep would be beneficial to sleep quality and potentially health.
The investigators will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). In a within-subject design, the investigators will test the hypotheses that exposure to a blue-depleted LED as compared to a CFL exposure at (1) 90 lux or (2) 50 lux will cause significantly:
- Less melatonin suppression between melatonin onset and bedtime;
- Less subjective and objective alerting responses before bedtime;
- Less disruption of nocturnal sleep structure and quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Stratified randomized crossover trial. Participants randomized between CFL and LED conditions stratified by light intensity (50 lux and 90 lux).
| Arm | Type | Receives |
|---|---|---|
| Compact Fluorescent Light 90 lux | Active comparator | Device: Visible light90 lux exposure of a commercially available Compact Fluorescent Light (CFL). |
| Blue-depleted LED light 90 lux | Experimental | Device: Visible light90 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). |
| Compact Fluorescent Light 50 lux | Active comparator | Device: Visible light50 lux exposure of a commercially available Compact Fluorescent Light (CFL). |
| Blue-depleted LED light 50 lux | Experimental | Device: Visible light50 lux exposure of a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged between 18-30 years to reduce the confounding effects of lens aging on the transmission of light to the retina;
- Non-smoking for at least 6 months;
- Healthy (no medical, psychiatric or sleep disorders);
- No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, urine chemistry and ECG;
- Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative urine pregnancy test;
Key exclusion criteria (11 listed)
- History of alcohol or substance abuse;
- Positive result on drugs of abuse screening;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
- Psychiatric disorder;
- Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
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 |
|---|---|---|
| Visible lightWe will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL). | Device | Blue-depleted LED light 50 lux, Blue-depleted LED light 90 lux, Compact Fluorescent Light 50 lux, Compact Fluorescent Light 90 lux |
Primary outcome
Melatonin Suppression
Time frame: 6-h constant posture interval of the light exposure
Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. AUC was calculated during the 6 h of light exposure and the corresponding 6-h interval 24 hours earlier. Higher values indicate more light-induced melatonin suppression.
4 secondary outcomes
Sleep Structure
Time frame: 8-h time in bed immediately following CFL/LED light exposure.
Sleep Quality
Time frame: First morning after 8-h time in bed immediately following CFL/LED light exposure.
Subjective Alerting Response
Time frame: 6-h constant posture interval of the light exposure.
Objective Alerting Response
Time frame: 6-h constant posture interval of the light exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Non-visual Photoreception
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.
Steven W Lockley, Ph.D. principal investigator
Brigham and Women's Hospital; Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visible light in people with Non-visual Photoreception, run by Brigham and Women's Hospital 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 9 inclusion and 11 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 14 Sep 2021. 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 5 Mar 2021). 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?
Melatonin Suppression (time frame: 6-h constant posture interval of the light exposure). 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 14 Sep 2021.