Trials / Completed
CompletedNCT05963555
PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly
Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- West Virginia University · Academic / Other
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NovoThor | 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. |
| DEVICE | VieLight | 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. |
| DEVICE | ZeroBody | 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. |
Timeline
- Start date
- 2023-07-31
- Primary completion
- 2025-03-25
- Completion
- 2025-03-25
- First posted
- 2023-07-27
- Last updated
- 2025-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05963555. Inclusion in this directory is not an endorsement.