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.

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality
• Intervention / Treatment: Device: NovoThor; Device: ZeroBody; Device: VieLight

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • WVU Rockefeller Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole-Body Photobiomodulation; Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.	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.
Experimental: Dry Float; 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.	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.
Experimental: Localized Photobiomodulation; Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.	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.
No Intervention: Control; Participants in the control group will be asked to keep their normal daily routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Sleep Quality; Photobiomodulation; Dry Float
• Other Study ID Numbers: 2303738136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No