Sleep QualityNCT05116605
Examining the Differential Effects of Photobiomodulation on Sleep and Performance
A study testing Photobiomodulation (PBM) in people with Sleep Quality, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Photobiomodulation (PBM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-50 years of age
Who cannot join
- 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
Show all 22Show fewer
- 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:
- Presenting with an absolute contraindication OR
- Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
- Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
- presenting with two or more relative contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- Photobiomodulation (PBM)
- Keywords
- Photobiomodulation, Sleep, Wearable Technology
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation (PBM)Other
Also called NovoTHOR Whole Body Light Bed
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation (PBM) | Experimental | Participants will utilize the NovoTHOR whole body light pod Receives: Other: Photobiomodulation (PBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: Changes from baseline versus end of study week 8
Secondary outcomes (2)
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
Measured: Weekly throughout study completion at 8 weeks
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.
Measured: Monthly from baseline through study completion at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start25 Oct 2021
- Primary completion1 Nov 2022
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116605
- Sponsor's protocol ID
- 2104299326
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2021
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Differential Effects of Photobiomodulation on Sleep and Performance
- ClinicalTrials.gov ID
- NCT05116605
- Acronym / sponsor ID
- 2104299326
- Conditions
- Sleep Quality
- Keywords
- Photobiomodulation, Sleep, Wearable Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) | Experimental | Other: Photobiomodulation (PBM)Participants will utilize the NovoTHOR whole body light pod |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female 18-50 years of age
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation (PBM)Also: NovoTHOR Whole Body Light BedPhotobiomodulation (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 | Photobiomodulation (PBM) |
Primary outcome
Change in Nocturnal Heart Rate as measured by OURA Ring
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.
Change in Subjective Sleep Quality
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.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate variability will be quantified throughout the night via the OURA ring.
Subjective Success of PBM assessed via Survey
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.
Changes in Subjective Anxiety as measured via the STAI
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.
Changes in Subjective Sleep as measured via PSQI
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.
Changes in Perceived Stress as measured via PSS
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.
Change in Subjective Epworth Sleepiness Scale measured via questionnaire
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
Change in Eriksen Flanker Task
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.
Change in Psychomotor Vigilance Task
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).
2 secondary outcomes
Change in Subjective Restorative Sleep Questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Time frame: Monthly from baseline through study completion at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation (PBM) in people with Sleep Quality, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Heart Rate as measured by OURA Ring (time frame: Daily from baseline through study completion at 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.