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

Not Applicable

Completed

• Conditions: Sleep Quality
• Interventions: Device: NovoThor; Device: ZeroBody; Device: VieLight

• Registration Number: NCT05963555
• Lead Sponsor: West Virginia University

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.

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Study Start: 2023-07-31
• Status Verified: 2025-02
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole-Body Photobiomodulation	NovoThor	Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.
Dry Float	ZeroBody	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.
Localized Photobiomodulation	VieLight	Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.

Primary Outcome Measures

Name	Time	Method
Changes in total sleep via Oura Ring	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.
Changes in resting state electroencephalography (EEG)	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.
Changes in the Circadian Sleep Inventory	Changes from baseline versus end of study week 18	Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.
Changes in the Patient Health Questionnaire (PHQ-9)	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

Trial Locations

Locations (1)

WVU Rockefeller Neuroscience Institute; 🇺🇸 Morgantown, West Virginia, United States