Clinical trial NCT05116605: Examining the Differential Effects of Photobiomodulation on Sleep and Performance
Official title: Examining the Differential Effects of Photobiomodulation on Sleep and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Photobiomodulation
Sleep
Wearable Technology
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Nocturnal Heart Rate as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Subjective Sleep Quality
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Nocturnal Heart Rate Variability as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Subjective Success of PBM assessed via Survey
timeFrame: Once at the end of week 8
measure: Changes in Subjective Anxiety as measured via the STAI
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Subjective Sleep as measured via PSQI
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Perceived Stress as measured via PSS
timeFrame: Weekly from baseline through study completion at 8 weeks
measure: Change in Subjective Epworth Sleepiness Scale measured via questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Change in Eriksen Flanker Task
timeFrame: Changes from baseline versus end of study week 8
measure: Change in Psychomotor Vigilance Task
timeFrame: Changes from baseline versus end of study week 8
Secondary outcomes:
measure: Change in Subjective Restorative Sleep Questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
timeFrame: Monthly from baseline through study completion at 8 weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: