An interventional study of Traditional Float-REST Therapy in Sleep Quality, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by West Virginia University · Not applicable, Interventional, and Basic science
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.
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.).
West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
Does not meet the ACSM's guidelines for exercise prescription. This is defined as:
Presenting with an absolute contraindication OR
Participants will utilize sensory deprivation tanks.
Other: Traditional Float-REST Therapy
Traditional Float-REST 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. The room will contain an intercom that allows participants to communicate with study personnel in the event they need assistance. Participants will undergo 60 minute sessions three times a week for 3 weeks.
Also known as: Sensory Deprivation Tanks
Change in Nocturnal Heart Rate as measured by OURA Ring
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Sleep Quantity as measured by Electroencephalography
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.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Subjective Sleep Quality
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.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Heart rate variability will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 8 weeks
Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index
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.
Time frame: Before and after each float session (Weeks 5-7)
Change in heart rate during Float-REST as measured via Electrocardiography
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Time frame: During each float session (weeks 5-7)
Change in heart rate variability during Float-REST as measured via Electrocardiography
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Time frame: During each float session (weeks 5-7)
Change in Subjective Athens Insomnia Scale measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Athens Insomnia Scale (AIS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = greater difficulty.
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Epworth Sleepiness Scale measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Epworth Sleepiness Scale (ESS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased average sleep propensity in daily life
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Insomnia Severity Index measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Insomnia Severity Index (ISI) - seven-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased severity.
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Restorative Sleep Questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Restorative Sleep Questionnaire (RSQ) - nine-item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = better sleep
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks). Patient Reported Outcomes Measurement Information System (PROMIS) - seven item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = healthier subject
Time frame: Weekly throughout study completion at 8 weeks
Subjective Sleep Preferences
At intake, a custom baseline questionnaire will be completed to record each participants sleep preferences and common behaviors. These sleep preferences will be used to identify if Float-REST tends to be more or less successful for certain individuals based upon predetermined qualities.
Time frame: Once at the beginning of week 1
Subjective Success of Float-REST
Following completion of the study, a custom questionnaire will record how successful the participant believes Float-REST was for improving their sleep and well-being. Participants will indicate how much they relate to a particular item on a scale of "Not at all" to "Very much so"
Time frame: Once at the end of week 8
Changes in Conflict Management via Questionnaire
Participants ability to manage conflict and the strategies in which they approach conflict will be assessed via the Conflict Management Questionnaire. This questionnaire scores the management of various situations based upon the participant responses (definitely true, true, tends to be true, tends not to be true, not true, definitely not true) and classifies the highest scoring response category as being the participant's preferred method of handing conflict. Scores of the response categories will be compared.
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire
Participants' ability to regulate their emotions appropriately will be quantified via the previously validated Emotional Regulation Questionnaire (ERQ), in which participants will indicate how much they agree with each statement (1, strongly disagree; 7, strongly agree).
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Perceived Stress as measured via Perceived Stress Scale
Participants' perceived stress will be quantified via the previously validated Perceived Stress Scale (PSS), which asks participants to report on the frequency of various experiences (0, never; 4, very often) and final scoring suggests lower scores to be associated with lower levels of stress.
Time frame: Weekly from baseline through study completion at 8 weeks
Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index
Participant's subjective reports of sleep quality will be quantified through the previously validated Pittsburgh Sleep Quality Index (PSQI). Questions are scored into multiple components to determine sleep difficulty in various areas, where higher scores are indicative of greater sleep difficulties; these scores will be compared across timepoints.
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Subjective Anxiety as measured via the State Trait Anxiety Index
Participants will complete the previously validated State Trait Anxiety Index (STAI) as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety.
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Participants will complete a 34 item checklist that has been previously used for screening of a potential sleep disorder; the more items that the participant feels applies to them, the higher the likelihood of the individual having a sleep disorder.
Time frame: Monthly from baseline through study completion at 8 weeks
Change in Cognitive Performance via Stroop Task
Participants will complete the Stroop Task at intake and once weekly throughout the study on a computer. The task requires participants to respond to the presentation of a word by clicking the key associated with the ink color rather than the meaning of the word. Participants will be monitored for speed and accuracy of responses.
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Response Inhibition via SART 2
Participants will complete the SART 2 task at intake and once weekly throughout the study on a computer. The task requires participants to respond, or refrain from responding, to the presentation of a number; a predetermined number is provided at the start of the task that participants are asked to refrain from responding to. Participants will be monitored for speed and accuracy of responses.
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Attentional Vigilance via Mackworth Clock Task
Participants will complete the Mackworth Clock task at intake and once weekly throughout the study on a computer. The task requires participants to watch the second hand of a clock across five minutes and respond as quickly as possible to skips in the clock's second hand by pressing a key. Participants will be monitored throughout the task for speed and accuracy of responses.
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Mental Rotation via Computer Task
Participants will complete the Mental Rotation task at intake and once monthly throughout the study on a computer. The task requires participants to respond as quickly as possible by select from two pictures that accurately depicts the same object that is presented in a different position in a third picture. 10 warm up trials will be completed followed by 10 test trials. Participants will be monitored throughout the task for speed and accuracy of responses.
Time frame: Monthly from baseline through study completion at 8 weeks.
Plan to share: Undecided
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West Virginia University