Examining the Differential Effects of Photobiomodulation on Sleep and Performance

NCT05116605 | Completed

• 1 other identifier: 2104299326
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research study is to assess how the implementation of photobiomodulation affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.

Conditions

Sleep Quality

Keywords

Photobiomodulation; Sleep; Wearable Technology

Outcome Measures

Primary Outcomes (10)

• Change in Nocturnal Heart Rate as measured by OURA Ring

  Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.

  Daily from baseline through study completion at 8 weeks

• Change in Subjective Sleep Quality

  A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.

  Daily from baseline through study completion at 8 weeks

• Change in Nocturnal Heart Rate Variability as measured by OURA Ring

  Heart rate variability will be quantified throughout the night via the OURA ring.

  Daily from baseline through study completion at 8 weeks

• Subjective Success of PBM assessed via Survey

  Following completion of the study, a custom questionnaire will record how successful the participant believes PBM was in improving their sleep and well being.

  Once at the end of week 8

• Changes in Subjective Anxiety as measured via the STAI

  Participants will complete the previously validated State Trait Anxiety Index (STAI) as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety.

  Monthly from baseline through study completion at 8 weeks

• Changes in Subjective Sleep as measured via PSQI

  Participant's subjective reports of sleep quality will be quantified through the previously validated Pittsburgh Sleep Quality Index (PSQI). Questions are scored into multiple components to determine sleep difficulty in various areas, where higher scores are indicative of greater sleep difficulties; these scores will be compared across timepoints.

  Monthly from baseline through study completion at 8 weeks

• Changes in Perceived Stress as measured via PSS

  Participants' perceived stress will be quantified via the previously validated Perceived Stress Scale (PSS), which asks participants to report on the frequency of various experiences (0, never; 4, very often) and final scoring suggests lower scores to be associated with lower levels of stress.

  Weekly from baseline through study completion at 8 weeks

• Change in Subjective Epworth Sleepiness Scale measured via questionnaire

  Participants will complete previously validated questionnaires as often as weekly. Epworth Sleepiness Scale (ESS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased average sleep propensity in daily life

  Weekly throughout study completion at 8 weeks

• Change in Eriksen Flanker Task

  The Flanker Task is a response inhibition test used to assess the participant's ability to suppress a response that is inappropriate based on the task rules. Participants are to respond, left or right, to the direction of the middle arrow (target arrow) of five aligned items. The task consists of congruent stimulus (the direction of the target arrow and flanker arrows are the same), incongruent stimulus (the direction of the target arrow is opposite of the flanker arrows), and neutral stimulus (flanker items are different then the target arrow). The dependent variable is the measurement of reaction time to select the direction of the target arrow.

  Changes from baseline versus end of study week 8

• Change in Psychomotor Vigilance Task

  A reaction time test that measures a person's sustained attention to a cue presented on a screen at random inter-stimulus intervals. In addition to the measures of reaction time to correct responses the errors of commission (responding when there is not response cue) and omission (failing to respond to a response cue).

  Changes from baseline versus end of study week 8

Secondary Outcomes (2)

• Change in Subjective Restorative Sleep Questionnaire

  Weekly throughout study completion at 8 weeks

• Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire

  Monthly from baseline through study completion at 8 weeks

Study Arms (1)

Photobiomodulation (PBM)

EXPERIMENTAL

Participants will utilize the NovoTHOR whole body light pod

Other: Photobiomodulation (PBM)

Interventions

Photobiomodulation (PBM) OTHER

Photobiomodulation (PBM) is light therapy in both the visible and near-infrared range (non-UV). This light is absorbed through the skin and functions at the cellular level, providing a lowering of inflammation and oxidative stress. Participants will undergo 20 minute sessions three times a week for 4 weeks using the NovoTHOR as the only intervention.

Also known as: NovoTHOR Whole Body Light Bed

Photobiomodulation (PBM)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18-50 years of age

You may not qualify if:

• Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
• Exceeds 290 pounds in body weight
• Has photophobia (light sensitivity)
• Has epilepsy or is prone to seizures
• Has thyroid problems or has been medicated for thyroid issues
• Has a current lower body musculoskeletal injury
• Has a current injury requiring an irremovable cast
• Is pregnant or actively trying to become pregnant
• Has a known or diagnosed sleep disorder
• Females who have become menopausal or are exhibiting signs or symptoms of becoming perimenopausal
• Females who are unable to identify when their monthly menstrual period will occur
• Individuals who work during the night shift or have significantly abnormal sleep schedule
• Has undergone travel across more than two collective time zones in the last two weeks
• Individuals who intend to have any significant medical procedures scheduled to occur within 12 weeks of enrollment
• Individuals who have intentions, or have discussed with their doctor, about adding or making any alterations to their prescribed medications within 12 weeks of enrollment

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete the following design. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 \& 8 for consistency. Baseline block (weeks 1-4): At intake, participants will complete up to 13 surveys, which includes 2 baseline questionnaires, \& the first rendition of weekly \& monthly surveys, as well as complete a physical performance task \& 4 cognitive tasks. Participants will complete daily surveys each morning \& night, \& wear wearable devices to monitor physiology during sleep. A laboratory visit will occur once per week for completion of weekly surveys, as well as cognitive \& physical performance assessments; monthly surveys will also be completed during the fourth week. Intervention block (weeks 5-8): Daily, weekly, \& monthly activities described for the baseline block will continue; participants will additionally complete three 20-minute PBM sessions per week. The final week of this block will also involve an exit survey.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 11, 2021
• Study Start: October 25, 2021
• Primary Completion: November 1, 2022
• Study Completion: July 20, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (1)