Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963555
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-07-19
Brief Title:
PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly
Sponsor:
West Virginia University
Organization:
West Virginia University
Study Overview
Official Title:
Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 quantityquality
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- 3xweek for 12 weeks at least 75 of the total sessions if applicable
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 quantityquality
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- 3xweek for 12 weeks at least 75 of the total sessions if applicable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None