Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:33 AM
Study NCT ID:
NCT07465250
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Combined Blue and Red Home-Based Light Therapy on Sleep in Adults With Self-Reported Sleep Difficulties
Sponsor:
Colorado State University
Organization:
Study Overview
Official Title:
IMPACT OF LIGHT THERAPY ON SLEEP AND PERFORMANCE
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: