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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.
In summary the study participants are expected to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Localized Photobiomodulation | Experimental | Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region. |
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| Control | No Intervention | Participants in the control group will be asked to keep their normal daily routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoThor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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. | Changes from baseline versus end of study week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Rockefeller Neuroscience Institute | Morgantown | West Virginia | 26505 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| VieLight | Device | 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. |
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| ZeroBody | Device | 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. |
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| D001523 |
| Mental Disorders |