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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05963555
Enrollment
15
Registered
2023-07-27
Start date
2023-07-31
Completion date
2025-03-25
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality

Keywords

Sleep Quality, Photobiomodulation, Dry Float

Brief 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.

Interventions

DEVICENovoThor

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.

DEVICEVieLight

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.

DEVICEZeroBody

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.

Sponsors

West Virginia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female between 50-85 years of age * Able and willing to give informed consent * No significant untreated medical history

Exclusion criteria

* Have no mental or physical conditions that are deemed inappropriate for study participation at investigator's discretion.

Design outcomes

Primary

MeasureTime frameDescription
Changes in resting state electroencephalography (EEG)Changes from baseline versus end of study week 18Electroencephalography (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)Changes from baseline versus end of study week 18Participants 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 RingChanges from baseline versus end of study week 18Oura 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 InventoryChanges from baseline versus end of study week 18Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026