Clinical trial NCT05963555: PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly
Official title: Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Sleep Quality
Photobiomodulation
Dry Float
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Changes in resting state electroencephalography (EEG)
timeFrame: Changes from baseline versus end of study week 18
measure: Changes in the Patient Health Questionnaire (PHQ-9)
timeFrame: Changes from baseline versus end of study week 18
measure: Changes in total sleep via Oura Ring
timeFrame: Changes from baseline versus end of study week 18
measure: Changes in the Circadian Sleep Inventory
timeFrame: Changes from baseline versus end of study week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
References: