Clinical trial NCT05154032: Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery
Official title: Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Sleep
Sensory Deprivation Tank
Wearable Technology
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete the following design. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 and 8 for consistency.

Baseline block (weeks 1-4): At intake, participants will complete up to 13 surveys, which includes two baseline questionnaires, \& the first rendition of weekly and monthly surveys. Participants will complete daily surveys each morning \& night, \& wear wearable devices to monitor physiology during sleep. Additionally, a laboratory visit will occur once per week for completion of weekly surveys \& cognitive assessments; monthly surveys will also be completed during the fourth week.

Intervention block (weeks 5-8): Daily, weekly, \& monthly activities described for the baseline block will continue. Additionally, during weeks 5-7, participants will complete three 60-minute Float-REST sessions per week; The final week of this block will only involve the daily, weekly \& monthly activities plus an exit survey.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this research study is to assess how the implementation of Float-REST affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.

Detailed description: Traditional flotation therapy (Float-REST; Flotation Restricted Environmental Stimulation Therapy) uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant to eliminate the gravitational effects on the body, and along with lack of sound and low to no light (depending on comfort) allows the brain and body to completely relax for augmented physical and mental recovery. Previous studies have examined the effects of sensory-deprivation tanks on both subjective (e.g., perceived stress and anxiety, self-reported muscle soreness) and objective measures of recovery (e.g., blood pressure, skill performance) though findings are incomplete and contradictory. Additionally, provided the growing understanding that sleep quality and quantity are at the forefront of ensuring optimal human performance states, compounded by the deleterious effects of high stress and anxiety on sleep, utilizing flotation therapy as a mechanism for enhancing sleep requires further investigation.

To identify whether Float-REST influences sleep and related behaviors, an eight week design will be executed that comprises an initial four weeks of baseline data collections followed by four weeks of intervention application and measure. Intervention will consist of three 60 minute Float-REST sessions per week, for the first three weeks of the intervention block (weeks 5-7 of the study). Data measures include wearable device monitoring, surveys, and brief cognitive tasks that are collected at various timepoints throughout the study (intake, monthly, weekly, daily, etc.).

Eligibility criteria: Inclusion Criteria:

* Male or female 18-50 years of age

Exclusion Criteria:

* Has undergone travel across more than two collective time zones in the last two weeks
* Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
* Has undergone a float-REST session of any kind in the last 3 months
* Has a fresh piercings that is less than 6 weeks old from scheduled session
* Has a fresh tattoo that is less than 4 weeks old from scheduled float
* Has an injury requiring an orthopedic cast (i.e. plaster or synthetic), irremovable splint or brace
* Is claustrophobic (fear of confined spaces)
* Has a skin or respiratory sensitivity or allergy to chlorine, sulfate, and/or magnesium
* Has a history of or is prone to motion sickness
* Has had an episode of loss of consciousness in the last 6-months
* Has had a concussion or traumatic brain injury in the last 6-months
* Has a contagious skin condition Has skin ulcers, open rashes, incisions, stiches or large open wounds that could cause pain when exposed to saltwater
* Has an irremovable medical port or catheter
* Has had a seizure in the last 10 years
* Has communicable diseases (e.g. HIV, Hepatitis A, B \& C, tuberculosis, or measles)
* Lack of control of bodily functions prior to scheduled float
* Is pregnant or actively trying to become pregnant
* Has a known or diagnosed sleep disorder
* Females who have become menopausal or are exhibiting signs or symptoms of becoming perimenopausal
* Females who are unable to identify when their monthly menstrual period will occur
* Individuals who work during the night shift or have significantly abnormal sleep schedule
* Individuals who intend to have any significant medical procedures scheduled to occur within 12 weeks of enrollment
* Individuals who have intentions, or have discussed with their doctor, about adding or making any alterations to their prescribed medications within 12 weeks of enrollment
* Individuals who have any travel plans or other obligations within 12 weeks of enrollment that would prevent them from completing study requirements and attending required laboratory visits
* Individuals who intend to make significant alterations to their sleeping patterns within 12 weeks of enrollment. This may include, but is not limited to, changes such as moving, getting a new mattress, having someone move in with them, etc.
* Does not meet the ACSM's guidelines for exercise prescription. This is defined as:

  1. Presenting with an absolute contraindication OR

     1. Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
     2. Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
  2. presenting with two or more relative contraindications

Primary outcomes:
measure: Change in Nocturnal Heart Rate as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Sleep Quantity as measured by Electroencephalography
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Subjective Sleep Quality
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Nocturnal Heart Rate Variability as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index
timeFrame: Before and after each float session (Weeks 5-7)
measure: Change in heart rate during Float-REST as measured via Electrocardiography
timeFrame: During each float session (weeks 5-7)
measure: Change in heart rate variability during Float-REST as measured via Electrocardiography
timeFrame: During each float session (weeks 5-7)
Secondary outcomes:
measure: Change in Subjective Athens Insomnia Scale measured via questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Change in Subjective Epworth Sleepiness Scale measured via questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Change in Subjective Insomnia Severity Index measured via questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Change in Subjective Restorative Sleep Questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire
timeFrame: Weekly throughout study completion at 8 weeks
measure: Subjective Sleep Preferences
timeFrame: Once at the beginning of week 1
measure: Subjective Success of Float-REST
timeFrame: Once at the end of week 8
measure: Changes in Conflict Management via Questionnaire
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Perceived Stress as measured via Perceived Stress Scale
timeFrame: Weekly from baseline through study completion at 8 weeks
measure: Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Subjective Anxiety as measured via the State Trait Anxiety Index
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
timeFrame: Monthly from baseline through study completion at 8 weeks
measure: Change in Cognitive Performance via Stroop Task
timeFrame: Weekly from baseline through study completion at 8 weeks.
measure: Change in Response Inhibition via SART 2
timeFrame: Weekly from baseline through study completion at 8 weeks.
measure: Change in Attentional Vigilance via Mackworth Clock Task
timeFrame: Weekly from baseline through study completion at 8 weeks.
measure: Change in Mental Rotation via Computer Task
timeFrame: Monthly from baseline through study completion at 8 weeks.
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: