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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05963555
• Other study ID #: 2303738136
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 2027
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	WVU Rockefeller Neuroscience Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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