SleepNCT07465250
Effects of Combined Blue and Red Home-Based Light Therapy on Sleep in Adults With Self-Reported Sleep Difficulties
A study testing LED portable light therapy bulb in people with Sleep, run by Colorado State University at 1 site in United States.
Trial summary
The goal of this intervention is to learn if a combination of morning blue light and evening red light therapy can improve sleep quality in adults with subclinical sleep complaints (non-diagnosed difficulty initiating or maintaining sleep). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- LED portable light therapy bulb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 7 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 and older
- Subclinical complaints of disrupted sleep or poor sleep quality
- a score of 3 or greater on the Pittsburgh Sleep Quality Index (PSQI)
Who cannot join
- Younger than 18 years of age,
- Complaints of disrupted or poor sleep with a PSQI score of less than 2
- Previously diagnosed clinical sleep disorder, such as insomnia or Circadian Rhythm Sleep Disorder (CRSD)
- Employment in evening, night, or rotating shifts
- Engagement in irregular sleep patterns that are not aligned with the biological night
- Inability to comply with the study protocol and at-home study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: IMPACT OF LIGHT THERAPY ON SLEEP AND PERFORMANCE
The goal of this intervention is to learn if a combination of morning blue light and evening red light therapy can improve sleep quality in adults with subclinical sleep complaints (non-diagnosed difficulty initiating or maintaining sleep).
The main questions it aims to answer are:
Does combined morning blue light and evening red light therapy reduce sleep onset latency (the time it takes to fall asleep) and improve sleep efficiency? Does this light therapy intervention improve subjective alertness upon awakening? Researchers will compare each participant's objective and subjective sleep data during a 7-day baseline (habitual routine) with their data during a 7-day light therapy intervention to assess whether light therapy improves sleep and daytime alertness.
Read the detailed description
Average sleep duration in American adults has decreased by nearly two hours over the last century, and the CDC has declared insufficient sleep a "public health problem." Inadequate sleep is linked to seven of the leading causes of death in the United States and contributes to significant economic loss through reduced productivity and accidents. While pharmacologic aids are commonly used by those with subclinical sleep issues, these often result in dependency and side effects like daytime drowsiness. Consequently, there is a clear need for non-pharmacologic interventions that can improve sleep quality and daytime alertness.
Visible light is the primary driver for synchronizing the human biological clock to the 24-hour solar cycle. Within the visible spectrum, short-wavelength "blue" light is a potent synchronizer that enhances alertness and resets circadian rhythms. Conversely, long-wavelength "red" light mimics the natural light environment of sunset and firelight; it minimally suppresses melatonin, making it less disruptive to the biological night. Despite evidence supporting light therapy for diagnosed sleep disorders, its effectiveness in individuals with subclinical sleep issues-a much larger portion of the population-remains largely unknown.
The overall objective of this study is to examine whether a combination of morning blue light and evening red light exposure can serve as an effective countermeasure for poor sleep quality and daytime fatigue. The central hypothesis is that this dual-light intervention will improve both objective and subjective sleep quality and increase subjective alertness upon awakening in adults with subclinical sleep complaints.
To test this hypothesis, the investigators will conduct a within-subject consecutive design study in 25 adults (aged 18+). Participants will first complete a 7-day baseline period to establish their habitual sleep patterns (Control condition). This is followed immediately by a 7-day intervention period (Treatment condition) consisting of 2 hours of morning blue light exposure and 2 hours of evening red light exposure. Sleep will be monitored objectively via 24-hour wrist-worn actigraphy and subjectively via daily sleep logs and the Leeds Sleep Evaluation Questionnaire (LSEQ). Subjective alertness and sleepiness will be assessed daily using the Karolinska Sleepiness Scale (KSS) and Visual Analog Scales (VAS).
Completion of this study will help bridge the gap in literature regarding light therapy's efficacy for subclinical populations. By identifying a non-pharmacological tool to improve sleep onset and morning alertness, this research aims to provide practical applications for lighting design and public health strategies to combat the risks of insufficient sleep.
- Conditions
- Sleep
- Being tested
- LED portable light therapy bulb
- Keywords
- light therapy, phototherapy, blue light exposure, red light exposure, sleep quality, sleep, actigraphy
- 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.
LED portable light therapy bulbOther
Also called light therapy, Blue light, red light
Unlike studies that use only bright white light or single-wavelength blue light, this intervention combines morning short-wavelength (blue) light with evening long-wavelength (red) light.
This study specifically targets individuals with "subclinical" sleep complaints-those with a Pittsburgh Sleep Quality Index (PSQI) score >1-rather than patients already diagnosed with clinical insomnia or Circadian Rhythm Sleep Disorders.
The protocol requires a precise 4-hour daily total exposure (2 hours in the morning and 2 hours in the evening), which is more intensive than many standard 30-minute light box protocols.
This is an at-home intervention where participants use portable lamp mounting options to integrate 4 hours of therapy into their regular daily activities, rather than receiving treatment in a controlled laboratory setting.
| Study group | Role | What they receive |
|---|---|---|
| LED Light Therapy | Experimental | Participants in this single-arm study follow a within-subject consecutive design. All participants complete a 7-day baseline period (Control) following their habitual routine, followed immediately by a 7-day intervention period (Treatment).
The intervention consists of:
Morning Exposure: 2 hours of short-wavelength blue light exposure immediately upon waking.
Evening Exposure: 2 hours of long-wavelength red light exposure during the 2 hours prior to the participant's anticipated bedtime.
The primary goal of this arm is to assess the impact of this dual-light protocol on objective sleep onset latency and subjective morning alertness compared to the participant's own baseline data. Receives: Other: LED portable light therapy bulb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency
Sleep Onset Latency (SOL) is the amount of time (measured in minutes) it takes a participant to fall asleep after getting into bed. This will be measured objectively using a 24-hour wrist-worn actigraphy device. The study will compare the average SOL during the 7-day habitual baseline period (Control) to the average SOL during the 7-day light therapy intervention period (Treatment) to assess the efficacy of the dual-spectrum light exposure.
Measured: Average of 7 days during the Control phase (Days 1-7) and average of 7 days during the Treatment phase (Days 8-14).
Secondary outcomes (2)
Total Sleep Time
Total Sleep Time (TST) is defined as the actual amount of time spent sleeping during the primary sleep episode, excluding any time spent awake after sleep onset. The study will compare the average TST during the 7-day habitual baseline period (Control) to the average TST during the 7-day light therapy intervention period (Treatment) to determine if the dual-spectrum light exposure increases overall sleep duration.
Measured: Average of 7 days during the Control phase (Days 1-7) and average of 7 days during the Treatment phase (Days 8-14).
Subjective Morning Alertness
Subjective alertness will be assessed using a 100-mm Visual Analog Scale (VAS) for alertness.
Participants mark a position on a line where 0 represents "not at all alert" and 100 represents "extremely alert".
Changes will be calculated by comparing the average morning scores (completed upon waking) during the 7-day baseline to the average scores during the 7-day intervention.
Measured: Daily upon awakening for 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start9 Jul 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a within-subject, consecutive design study in which each participant serves as their own control.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josiane Broussard, Colorado State University
- Investigators
- Josiane L Broussard, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465250
- Sponsor's protocol ID
- 5775
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF LIGHT THERAPY ON SLEEP AND PERFORMANCE
- ClinicalTrials.gov ID
- NCT07465250
- Acronym / sponsor ID
- 5775
- Conditions
- Sleep
- Keywords
- light therapy, phototherapy, blue light exposure, red light exposure, sleep quality, sleep, actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 11 Mar 2026 (actual)
- 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 goal of this intervention is to learn if a combination of morning blue light and evening red light therapy can improve sleep quality in adults with subclinical sleep complaints (non-diagnosed difficulty initiating or maintaining sleep).
The main questions it aims to answer are:
Does combined morning blue light and evening red light therapy reduce sleep onset latency (the time it takes to fall asleep) and improve sleep efficiency? Does this light therapy intervention improve subjective alertness upon awakening? Researchers will compare each participant's objective and subjective sleep data during a 7-day baseline (habitual routine) with their data during a 7-day light therapy intervention to assess whether light therapy improves sleep and daytime alertness.
Detailed description
Average sleep duration in American adults has decreased by nearly two hours over the last century, and the CDC has declared insufficient sleep a "public health problem." Inadequate sleep is linked to seven of the leading causes of death in the United States and contributes to significant economic loss through reduced productivity and accidents. While pharmacologic aids are commonly used by those with subclinical sleep issues, these often result in dependency and side effects like daytime drowsiness. Consequently, there is a clear need for non-pharmacologic interventions that can improve sleep quality and daytime alertness.
Visible light is the primary driver for synchronizing the human biological clock to the 24-hour solar cycle. Within the visible spectrum, short-wavelength "blue" light is a potent synchronizer that enhances alertness and resets circadian rhythms. Conversely, long-wavelength "red" light mimics the natural light environment of sunset and firelight; it minimally suppresses melatonin, making it less disruptive to the biological night. Despite evidence supporting light therapy for diagnosed sleep disorders, its effectiveness in individuals with subclinical sleep issues-a much larger portion of the population-remains largely unknown.
The overall objective of this study is to examine whether a combination of morning blue light and evening red light exposure can serve as an effective countermeasure for poor sleep quality and daytime fatigue. The central hypothesis is that this dual-light intervention will improve both objective and subjective sleep quality and increase subjective alertness upon awakening in adults with subclinical sleep complaints.
To test this hypothesis, the investigators will conduct a within-subject consecutive design study in 25 adults (aged 18+). Participants will first complete a 7-day baseline period to establish their habitual sleep patterns (Control condition). This is followed immediately by a 7-day intervention period (Treatment condition) consisting of 2 hours of morning blue light exposure and 2 hours of evening red light exposure. Sleep will be monitored objectively via 24-hour wrist-worn actigraphy and subjectively via daily sleep logs and the Leeds Sleep Evaluation Questionnaire (LSEQ). Subjective alertness and sleepiness will be assessed daily using the Karolinska Sleepiness Scale (KSS) and Visual Analog Scales (VAS).
Completion of this study will help bridge the gap in literature regarding light therapy's efficacy for subclinical populations. By identifying a non-pharmacological tool to improve sleep onset and morning alertness, this research aims to provide practical applications for lighting design and public health strategies to combat the risks of insufficient sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a within-subject, consecutive design study in which each participant serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| LED Light Therapy | Experimental | Other: LED portable light therapy bulbParticipants in this single-arm study follow a within-subject consecutive design. All participants complete a 7-day baseline period (Control) following their habitual routine, followed immediately by a 7-day intervention period (Treatment). The intervention consists of: Morning Exposure: 2 hours of short-wavelength blue light exposure immediately upon waking. Evening Exposure: 2 hours of long-wavelength red light exposure during the 2 hours prior to the participant's anticipated bedtime. The primary goal of this arm is to assess the impact of this dual-light protocol on objective sleep onset latency and subjective morning alertness compared to the participant's own baseline data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 and older
- Subclinical complaints of disrupted sleep or poor sleep quality
- a score of 3 or greater on the Pittsburgh Sleep Quality Index (PSQI)
Key exclusion criteria (6 listed)
- Younger than 18 years of age,
- Complaints of disrupted or poor sleep with a PSQI score of less than 2
- Previously diagnosed clinical sleep disorder, such as insomnia or Circadian Rhythm Sleep Disorder (CRSD)
- Employment in evening, night, or rotating shifts
- Engagement in irregular sleep patterns that are not aligned with the biological night
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 |
|---|---|---|
| LED portable light therapy bulbAlso: light therapy, Blue light, red lightUnlike studies that use only bright white light or single-wavelength blue light, this intervention combines morning short-wavelength (blue) light with evening long-wavelength (red) light. This study specifically targets individuals with "subclinical" sleep complaints-those with a Pittsburgh Sleep Quality Index (PSQI) score >1-rather than patients already diagnosed with clinical insomnia or Circadian Rhythm Sleep Disorders. The protocol requires a precise 4-hour daily total exposure (2 hours in the morning and 2 hours in the evening), which is more intensive than many standard 30-minute light box protocols. This is an at-home intervention where participants use portable lamp mounting options to integrate 4 hours of therapy into their regular daily activities, rather than receiving treatment in a controlled laboratory setting. | Other | LED Light Therapy |
Primary outcome
Sleep Onset Latency
Time frame: Average of 7 days during the Control phase (Days 1-7) and average of 7 days during the Treatment phase (Days 8-14).
Sleep Onset Latency (SOL) is the amount of time (measured in minutes) it takes a participant to fall asleep after getting into bed. This will be measured objectively using a 24-hour wrist-worn actigraphy device. The study will compare the average SOL during the 7-day habitual baseline period (Control) to the average SOL during the 7-day light therapy intervention period (Treatment) to assess the efficacy of the dual-spectrum light exposure.
2 secondary outcomes
Total Sleep Time
Time frame: Average of 7 days during the Control phase (Days 1-7) and average of 7 days during the Treatment phase (Days 8-14).
Subjective Morning Alertness
Time frame: Daily upon awakening for 15 days.
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 12 Mar 2026.
- Josiane Broussard's BibliographyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Josiane L Broussard, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED portable light therapy bulb in people with Sleep, run by Colorado State University 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 6 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 12 Mar 2026. 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?
Sleep Onset Latency (time frame: Average of 7 days during the Control phase (Days 1-7) and average of 7 days during the Treatment phase (Days 8-14).). 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 12 Mar 2026.