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

West Virginia University

Status: Completed

Conditions: Sleep Quality

Treatments: Device: VieLight; Device: ZeroBody; Device: NovoThor

Study type: Interventional

Funder types: Other

Identifiers

NCT05963555

2303738136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Whole-Body Photobiomodulation

Experimental group

Description:

Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.

Treatment:

Device: NovoThor

Dry Float

Experimental group

Description:

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.

Treatment:

Device: ZeroBody

Localized Photobiomodulation

Experimental group

Description:

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

Treatment:

Device: VieLight

Control

No Intervention group

Description:

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