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

NCT ID: NCT05963555

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-03-25

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.

Conditions

Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NovoThor

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

ZeroBody

Intervention Type: 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.

Localized Photobiomodulation

Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.

Group Type: EXPERIMENTAL

VieLight

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2303738136

Identifier Type: -

Identifier Source: org_study_id