Sleep QualityNCT05963555
PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly
A study testing NovoThor, VieLight and ZeroBody in people with Sleep Quality, run by West Virginia University at 1 site in United States.
Trial summary
The main objective of this study is to assess the impact of implementing photobiomodulation (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged and elderly individuals experiencing sleep disturbance. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- NovoThor, VieLight and ZeroBody
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 25 Mar 2025
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 50-85 years of age
- Able and willing to give informed consent
- No significant untreated medical history
Who cannot join
- Have no mental or physical conditions that are deemed inappropriate for study participation at investigator's discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
About this study
Official title: Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.
The main objective of this study is to assess the impact of implementing photobiomodulation (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged and elderly individuals experiencing sleep disturbance. As a secondary objective we will analyze the effect of the treatments on other indices of recovery (subjective and objective) via physiological monitoring in middle-aged and elderly individuals experiencing sleep disturbance.
The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data collection of sleep quality. Phase 2 contains the experimental conditions and will last 13 weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and at the end of experimental period (week 18). Sleep tracking data will be collected daily.
Read the detailed description
In summary the study participants are expected to:
- Wear a study provided smart ring (OURA Ring) through the end of the study period (at least 75% of the total study time) which measures sleep quantity/quality.
- Keep their smart phones nearby and charged while wearing their devices.
- Complete monthly surveys with questions about general well-being until the end of the study period.
- Complete a testing battery consisting of cognitive tests, behavioral and mood questionnaires, qEEG and physical assessments, in the beginning and at the end of the study period.
- Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of the total sessions), if applicable.
- Conditions
- Sleep Quality
- Being tested
- NovoThor, VieLight, ZeroBody
- Keywords
- Sleep Quality, Photobiomodulation, Dry Float
- 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.
NovoThorDevice
Following the baseline block (first four weeks), participants will use the NovoThor device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.
VieLightDevice
Following the baseline block (first four weeks), participants will use the VieLight device 2-3 times per week for 20 minute sessions and may be completed at home.
ZeroBodyDevice
Following the baseline block (first four weeks), participants will use the Zerobody device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Photobiomodulation | Experimental | Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed. Receives: Device: NovoThor |
| Dry Float | Experimental | Simulates the effects of traditional Float-REST therapy. Instead of contact with salt water, the dry float system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank. Receives: Device: ZeroBody |
| Localized Photobiomodulation | Experimental | Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region. Receives: Device: VieLight |
| Control | No intervention | Participants in the control group will be asked to keep their normal daily routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in resting state electroencephalography (EEG)
Electroencephalography (EEG) analysis looking for alterations in brain activity. A paired samples t-Test will be used to compare power activity at baseline and follow-up.
Measured: Changes from baseline versus end of study week 18
Changes in the Patient Health Questionnaire (PHQ-9)
Participants will complete the Patient Health Questionnaire (PHQ-9) once a month. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression
Measured: Changes from baseline versus end of study week 18
Changes in total sleep via Oura Ring
Oura Ring will be used to track total sleep throughout the study. Increased total sleep values will indicate better quality sleep and decrease total sleep values will indicate poorer sleep.
Measured: Changes from baseline versus end of study week 18
Changes in the Circadian Sleep Inventory
Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.
Measured: Changes from baseline versus end of study week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start31 Jul 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT05963555
- Sponsor's protocol ID
- 2303738136
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2023
- Last updated
- 24 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.
- ClinicalTrials.gov ID
- NCT05963555
- Acronym / sponsor ID
- 2303738136
- Conditions
- Sleep Quality
- Keywords
- Sleep Quality, Photobiomodulation, Dry Float
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 27 Jul 2023 (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 main objective of this study is to assess the impact of implementing photobiomodulation (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged and elderly individuals experiencing sleep disturbance. As a secondary objective we will analyze the effect of the treatments on other indices of recovery (subjective and objective) via physiological monitoring in middle-aged and elderly individuals experiencing sleep disturbance.
The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data collection of sleep quality. Phase 2 contains the experimental conditions and will last 13 weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and at the end of experimental period (week 18). Sleep tracking data will be collected daily.
Detailed description
In summary the study participants are expected to:
- Wear a study provided smart ring (OURA Ring) through the end of the study period (at least 75% of the total study time) which measures sleep quantity/quality.
- Keep their smart phones nearby and charged while wearing their devices.
- Complete monthly surveys with questions about general well-being until the end of the study period.
- Complete a testing battery consisting of cognitive tests, behavioral and mood questionnaires, qEEG and physical assessments, in the beginning and at the end of the study period.
- Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of the total sessions), if applicable.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Photobiomodulation | Experimental | Device: NovoThorLight therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed. |
| Dry Float | Experimental | Device: ZeroBodySimulates the effects of traditional Float-REST therapy. Instead of contact with salt water, the dry float system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank. |
| Localized Photobiomodulation | Experimental | Device: VieLightLight therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region. |
| Control | No intervention | –Participants in the control group will be asked to keep their normal daily routine. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between 50-85 years of age
- Able and willing to give informed consent
- No significant untreated medical history
Key exclusion criteria (1 listed)
- Have no mental or physical conditions that are deemed inappropriate for study participation at investigator's discretion.
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 |
|---|---|---|
| NovoThorFollowing the baseline block (first four weeks), participants will use the NovoThor device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute. | Device | Whole-Body Photobiomodulation |
| VieLightFollowing the baseline block (first four weeks), participants will use the VieLight device 2-3 times per week for 20 minute sessions and may be completed at home. | Device | Localized Photobiomodulation |
| ZeroBodyFollowing the baseline block (first four weeks), participants will use the Zerobody device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute. | Device | Dry Float |
Primary outcome
Changes in resting state electroencephalography (EEG)
Time frame: Changes from baseline versus end of study week 18
Electroencephalography (EEG) analysis looking for alterations in brain activity. A paired samples t-Test will be used to compare power activity at baseline and follow-up.
Changes in the Patient Health Questionnaire (PHQ-9)
Time frame: Changes from baseline versus end of study week 18
Participants will complete the Patient Health Questionnaire (PHQ-9) once a month. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression
Changes in total sleep via Oura Ring
Time frame: Changes from baseline versus end of study week 18
Oura Ring will be used to track total sleep throughout the study. Increased total sleep values will indicate better quality sleep and decrease total sleep values will indicate poorer sleep.
Changes in the Circadian Sleep Inventory
Time frame: Changes from baseline versus end of study week 18
Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.
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 24 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 NovoThor, VieLight and ZeroBody 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 3 inclusion and 1 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 24 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?
Changes in resting state electroencephalography (EEG) (time frame: Changes from baseline versus end of study week 18). The study lists 4 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 24 Apr 2025.