Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West Virginia University
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change in Nocturnal Heart Rate as measured by OURA Ring
Study Overview
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.).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •Presenting with an absolute contraindication OR
- •Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
- •Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
- •presenting with two or more relative contraindications
Outcomes
Primary Outcomes
Change in Nocturnal Heart Rate as measured by OURA Ring
Time Frame: Daily from baseline through study completion at 8 weeks
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in Sleep Quantity as measured by Electroencephalography
Time Frame: Daily from baseline through study completion at 8 weeks
Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses Electroencephalography (EEG) for automatic sleep stage scoring.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Time Frame: Daily from baseline through study completion at 8 weeks
Heart rate variability will be quantified throughout the night via the OURA ring.
Change in heart rate during Float-REST as measured via Electrocardiography
Time Frame: During each float session (weeks 5-7)
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Change in heart rate variability during Float-REST as measured via Electrocardiography
Time Frame: During each float session (weeks 5-7)
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Change in Subjective Sleep Quality
Time Frame: Daily from baseline through study completion at 8 weeks
A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.
Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index
Time Frame: Before and after each float session (Weeks 5-7)
Participants will complete the previously validated State Trait Anxiety Index (STAI) before and after each float session as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety. State-Trait Anxiety Index (STAI) - Commonly used measure of state and trait anxiety, and done with 20 very brief questions. Values range from 20 to 80, with higher scores representing more severe anxiety. Participants will complete the STAI questionnaire before and after each session. The sessions will take place during weeks 5-7.
Secondary Outcomes
- Change in Subjective Athens Insomnia Scale measured via questionnaire(Weekly throughout study completion at 8 weeks)
- Change in Cognitive Performance via Stroop Task(Weekly from baseline through study completion at 8 weeks.)
- Change in Subjective Restorative Sleep Questionnaire(Weekly throughout study completion at 8 weeks)
- Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire(Weekly throughout study completion at 8 weeks)
- Subjective Sleep Preferences(Once at the beginning of week 1)
- Change in Subjective Epworth Sleepiness Scale measured via questionnaire(Weekly throughout study completion at 8 weeks)
- Change in Mental Rotation via Computer Task(Monthly from baseline through study completion at 8 weeks.)
- Change in Subjective Insomnia Severity Index measured via questionnaire(Weekly throughout study completion at 8 weeks)
- Changes in Conflict Management via Questionnaire(Monthly from baseline through study completion at 8 weeks)
- Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire(Monthly from baseline through study completion at 8 weeks)
- Changes in Perceived Stress as measured via Perceived Stress Scale(Weekly from baseline through study completion at 8 weeks)
- Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index(Monthly from baseline through study completion at 8 weeks)
- Changes in Subjective Anxiety as measured via the State Trait Anxiety Index(Monthly from baseline through study completion at 8 weeks)
- Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire(Monthly from baseline through study completion at 8 weeks)
- Change in Attentional Vigilance via Mackworth Clock Task(Weekly from baseline through study completion at 8 weeks.)
- Subjective Success of Float-REST(Once at the end of week 8)
- Change in Response Inhibition via SART 2(Weekly from baseline through study completion at 8 weeks.)