Examining the Differential Effects of Photobiomodulation on Sleep and Performance

Sleep Quality Clinical Trial

Official title:

Examining the Differential Effects of Photobiomodulation on Sleep and Performance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116605
• Other study ID #: 2104299326
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: July 2026

Study information

• Verified date: December 2022
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. By provoking these photochemical changes, previous research indicates that PBM can provide both physical (e.g. pain reduction, strength enhancement) and cognitive benefits (e.g. increased memory extinction, improved cortical oxygen consumption). PBM is effective both preceding and succeeding functional tests, proving its ability to provide a preventative and rehabilitative impact on the functionality of cells and tissues. Metabolic changes to the cerebral cortex and the muscular system combine with anti-inflammatory and protective capabilities to augment recovery from physiological stressors. A plurality of literature reports light therapy given solely to specific body regions. However, partial body treatment may limit the comprehensive and systematic response to PBM treatment. Consequently, recent developments from commercial companies, such as NovoTHOR, have generated a consumer market for whole-body PBM. Yet, the physiological responses to these treatment modalities, as well as their effects on health and well-being is not fully understood.

Participants will undergo a four week block of baseline data collection, which involves nightly sleep monitoring, as well as daily, weekly, and monthly surveys and assessments. Following the baseline block, participants will complete a four week intervention block completing 3 PBM sessions per week. PBM sessions will be completed using the NovoThor light bed and will last 20 minutes in duration. Daily, weekly, and monthly monitoring and tasks will continue throughout this block.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: July 2026
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male or female 18-50 years of age

Exclusion Criteria:

• 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

• Individuals who have any travel plans or other obligations within 12 weeks of enrollment that would prevent them from completing study requirements and attending required laboratory visits

• Individuals who intend to make significant alterations to their sleeping patterns within 12 weeks of enrollment. This may include, but is not limited to, changes such as moving, getting a new mattress, having someone move in with them, etc.

• Does not meet the ACSM's guidelines for exercise prescription. This is defined as:

1. Presenting with an absolute contraindication OR

1. Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness

2. Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease

2. presenting with two or more relative contraindications

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Other:
• Photobiomodulation (PBM)
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.

Locations

Country	Name	City	State
United States	Rockefeller Neuroscience Institute at West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Sleep Quantity as measured by EEG	Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses EEG for automatic sleep stage scoring.	Daily from baseline through study completion at 8 weeks
Primary	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
Primary	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
Secondary	Change in Subjective Athens Insomnia Scale measured via questionnaire	Participants will complete previously validated questionnaires as often as weekly.; Athens Insomnia Scale (AIS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = greater difficulty.	Weekly throughout study completion at 8 weeks
Secondary	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
Secondary	Change in Subjective Insomnia Severity Index measured via questionnaire	Participants will complete previously validated questionnaires as often as weekly.; Insomnia Severity Index (ISI) - seven-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased severity.	Weekly throughout study completion at 8 weeks
Secondary	Change in Subjective Restorative Sleep Questionnaire	Participants will complete previously validated questionnaires as often as weekly.; Restorative Sleep Questionnaire (RSQ) - nine-item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = better sleep	Weekly throughout study completion at 8 weeks
Secondary	Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire	Participants will complete previously validated questionnaires as often as weekly.; Patient Reported Outcomes Measurement Information System (PROMIS) - seven item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = healthier subject	Weekly throughout study completion at 8 weeks
Secondary	Subjective Sleep Preferences	At intake, a custom baseline questionnaire will be completed to record each participants sleep preferences and common behaviors. These sleep preferences will be used to identify if PBM tends to be more or less successful for certain individuals based upon predetermined qualities.	Once at the beginning of week 1
Secondary	Changes in Conflict Management via Questionnaire	Participants ability to manage conflict and the strategies in which they approach conflict will be assessed via the Conflict Management Questionnaire. This questionnaire scores the management of various situations based upon the participant responses (definitely true, true, tends to be true, tends not to be true, not true, definitely not true) and classifies the highest scoring response category as being the participant's preferred method of handing conflict. Scores of the response categories will be compared.	Monthly from baseline through study completion at 8 weeks
Secondary	Changes in Emotional Regulation as measured via ERQ	Participants' ability to regulate their emotions appropriately will be quantified via the previously validated Emotional Regulation Questionnaire (ERQ), in which participants will indicate how much they agree with each statement (1, strongly disagree; 7, strongly agree).	Monthly from baseline through study completion at 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire	Participants will complete a 34 item checklist that has been previously used for screening of a potential sleep disorder; the more items that the participant feels applies to them, the higher the likelihood of the individual having a sleep disorder.	Monthly from baseline through study completion at 8 weeks
Secondary	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
Secondary	Change in Anaerobic Neuromuscular Performance	Participants will complete the previously used 30 second BOSCO test once at intake, as well as twice weekly. The BOSCO is a neuromuscular assessment that asks participants to jump as high and as quickly as they can, while spending as little time on the ground as possible, for 30 seconds. This task will be completed before and after the final PBM session each week in the intervention block and before and after 20 minutes of rest each week during the baseline block. Trends will be monitored throughout the task to quantify the rate of fatigue throughout the task.	Twice weekly from baseline through study completion at 8 weeks
Secondary	Change in Cognitive Performance via Stroop Task	Participants will complete the Stroop Task at intake and once weekly throughout the study on a computer. The task requires participants to respond to the presentation of a word by clicking the key associated with the ink color rather than the meaning of the word. Participants will be monitored for speed and accuracy of responses.	Weekly from baseline through study completion at 8 weeks
Secondary	Change in Response Inhibition via SART 2	Participants will complete the SART 2 task at intake and once weekly throughout the study on a computer. The task requires participants to respond, or refrain from responding, to the presentation of a number; a predetermined number is provided at the start of the task that participants are asked to refrain from responding to. Participants will be monitored for speed and accuracy of responses.	Weekly from baseline through study completion at 8 weeks
Secondary	Change in Attentional Vigilance via Mackworth Clock Task	Participants will complete the Mackworth Clock task at intake and once weekly throughout the study on a computer. The task requires participants to watch the second hand of a clock across five minutes and respond as quickly as possible to skips in the clock's second hand by pressing a key. Participants will be monitored throughout the task for speed and accuracy of responses.	Weekly from baseline through study completion at 8 weeks
Secondary	Change in Mental Rotation via Computer Task	Participants will complete the Mental Rotation task at intake and once monthly throughout the study on a computer. The task requires participants to respond as quickly as possible by select from two pictures that accurately depicts the same object that is presented in a different position in a third picture. 10 warm up trials will be completed followed by 10 test trials. Participants will be monitored throughout the task for speed and accuracy of responses.	Monthly from baseline through study completion at 8 weeks