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临床试验/NCT07465250
NCT07465250已完成不适用

IMPACT OF LIGHT THERAPY ON SLEEP AND PERFORMANCE

Colorado State University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Sleep Onset Latency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: LED portable light therapy bulb (Other)

结局指标

主要结局

Sleep Onset Latency

时间窗: 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.

次要结局

  • Total Sleep Time(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(Daily upon awakening for 15 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josiane Broussard

Associate Professor

Colorado State University

研究点 (1)

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