Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505, United States
NCT Number: NCT05116605
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.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Morgantown, West Virginia, 26505, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: NovoTHOR Whole Body Light Bed
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 8 weeks
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.
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate variability will be quantified throughout the night via the OURA ring.
Time frame: Once at the end of week 8
Following completion of the study, a custom questionnaire will record how successful the participant believes PBM was in improving their sleep and well being.
Time frame: Monthly from baseline through study completion at 8 weeks
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.
Time frame: Monthly from baseline through study completion at 8 weeks
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.
Time frame: Weekly from baseline through study completion at 8 weeks
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.
Time frame: Weekly throughout study completion at 8 weeks
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
Time frame: Changes from baseline versus end of study week 8
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.
Time frame: Changes from baseline versus end of study week 8
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).
Time frame: Weekly throughout study completion at 8 weeks
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
Time frame: Monthly from baseline through study completion at 8 weeks
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.
West Virginia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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