NCT07465250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 17, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

light therapyphototherapyblue light exposurered light exposuresleep qualitysleepactigraphy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

Study Arms (1)

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.

Other: LED portable light therapy bulb

Interventions

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.

Also known as: light therapy, Blue light, red light
LED Light Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

PhototherapyBlue LightRed Light

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Josiane L Broussard, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a within-subject, consecutive design study in which each participant serves as their own control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 11, 2026

Study Start

July 9, 2024

Primary Completion

July 7, 2025

Study Completion

July 7, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations