Skip to main content
OpenTrials
Completed

NCT Number: NCT05963555

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Changes in resting state electroencephalography (EEG)

    Time frame: Changes from baseline versus end of study week 18

    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.

  2. Changes in the Patient Health Questionnaire (PHQ-9)

    Time frame: Changes from baseline versus end of study week 18

    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

  3. Changes in total sleep via Oura Ring

    Time frame: Changes from baseline versus end of study week 18

    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.

  4. Changes in the Circadian Sleep Inventory

    Time frame: Changes from baseline versus end of study week 18

    Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.