PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly

NCT05963555 | Completed

• 1 other identifier: 2303738136
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality

Keywords

Sleep Quality; Photobiomodulation; Dry Float

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

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.

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.

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.

Device: VieLight

Control

NO INTERVENTION

Participants in the control group will be asked to keep their normal daily routine.

Interventions

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.

Whole-Body Photobiomodulation

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.

Localized Photobiomodulation

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.

Dry Float

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: July 31, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-02

Locations

US (1)