Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes

• ClinicalTrials.gov Identifier: NCT04628910
• Recruitment Status: Recruiting
• First Posted: November 16, 2020
• Last Update Posted: July 19, 2021
• Sponsor: West Virginia University
• Information provided by (Responsible Party): Scott Galster, West Virginia University

Study Description

Brief Summary:

The objective of this research study is to assess how the implementation of various modern strategies for augmented recovery affect sleep quality, subjective wellness and other indices of general well-being.

Condition or disease	Intervention/treatment	Phase
Sleep Quality	Other: Simulated Flotation Therapy; Other: Traditional Float-REST Therapy	Not Applicable

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. 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. In addition to the traditional Float- REST, there have been developments in newer technologies that enhance the convenience of receiving these proposed benefits; Zerobody Dry Float technology (www.Zerobody.com) rids the need for multiple showers by its user, frequent water treatments, and extensive maintenance experienced with traditional flotation environments. However, research is still needed to assess how this recovery modality compares to traditional Float-REST.

To assess whether traditional (Float-REST) or simulated (Dry Float) flotation therapy positively influences sleep and perceptual recovery, participants will undergo a crossover study. Over the course of 9 weeks, participants will alternate Float-REST and Dry Float in 3 week segments with a 1 week break in-between to gather baseline data (known as the testing battery). In addition, testing battery data will be collected at weeks 1 and 9. The order in which participants begin their crossover study, either Float-REST or Dry Float, will be randomly assigned. All participants may wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. In addition, daily, per session, and pre/post-study questionnaires will be submitted via a smartphone application.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

Intervention Model Description

Weeks 0-1: Testing battery; begin daily surveys and at home monitoring via smartphone applications. This will serve as baseline and will be collected for, at minimum, 5 days prior to the first experimental condition.

Weeks 2-4: Complete daily surveys and at home monitoring via smartphone applications; Complete the first experimental condition (Float-REST or Dry Float) in 60 minute sessions, twice a week.

Week 5: Complete daily surveys and at home monitoring via smartphone applications. A second round of the testing battery will be completed prior to beginning the next condition.

Week 6-8: Complete daily surveys and at home monitoring via smartphone applications; Complete the first experimental condition (Float-REST or Dry Float) in 60 minute sessions, twice a week.

Week 9: Complete daily surveys and at home monitoring via smartphone applications. The testing battery will be completed for the final time toward the end of the week and will signify their completion of the study.

• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Traditional Float-REST Therapy; 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 twice a week for 3 weeks as one of the two interventions.; Other Name: Sensory Deprivation Tanks
Experimental: Simulated Flotation Therapy; Participants will utilize the Zerobody dry flotation therapy.	Other: Simulated Flotation Therapy; The Zerobody is a new technology designed to simulate the effects of traditional Float-REST therapy, but without the contact with salt water. The system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank. The system will be housed in a room that allows for significant reductions in light and sound to mimic the experience of a flotation tank. 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 twice a week for 3 weeks using the Zerobody, also termed "dry floating," as one of the two interventions.; Other Name: Zerobody Dry Float

Outcome Measures

Primary Outcome Measures :

1. Change in sleep patterns as measured by OURA ring [ Time Frame: Daily from baseline through study completion at 9 weeks ]
   Oura Ring is a connected health device worn on the finger that measures sleep. Sleep summaries per day will be compared.
2. Change in daily self-report measures for recovery [ Time Frame: Daily from baseline through study completion at 9 weeks ]
   Short Recovery and Stress Scale (SRSS)-An 8 item inventory that assess subjective measures of physical, mental, and emotional recovery on a 7 point Likert Scale (0=does not apply at all to 6=fully applies). High values in overall recovery indicate feeling physically and mentally recovered. High values in overall stress indicate feeling overloaded and physically tired. This questionnaire addresses subjective measure of readiness for the day ahead.
3. Change in daily self-report measures for task load [ Time Frame: Daily from baseline through study completion at 9 weeks ]
   End of Day Questionnaire (EoD)-Developed at the Rockefeller Neuroscience Institute (RNI) as a modification of the NASA Task Load Index. There are 5 Likert scales to assess workload (0=very low and 100=very high), as well as 4 follow up questions. This questionnaire addresses subjective measures of workload and stressors that were encountered throughout the day.
4. Change in daily self-report measures in perceived exertion [ Time Frame: Daily from baseline through study completion at 9 weeks ]
   Post-Training Rating of Perceived Exertion Questionnaire (Post-Training RPE)- An adaption of the Borg Rating of Perceived Exertion scale, commonly referred to as RPE. The questionnaire requires participants to list the specific activity and the subjective measure of exercise intensity. The scale ranges from 6-20 (6=no exertion that is equivalent to rest and 20=maximal exertion). This questionnaire logs activity (i.e. workout, walk, run, hike) and address subjective exertion levels encountered exercise based activities throughout the day.
5. Change in per session self-report measures [ Time Frame: 2 times a week, in 3 week increments, through study completion at 9 weeks ]
   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, twice a week. The sessions will take place during weeks 2-4 and weeks 6-8.
6. Change in testing battery self-report measures in personality [ Time Frame: Week 1, week 5, and week 9 ]
   Big Five Inventory (BFI)-44 item inventory designed to measure the Big Five Factors of personality on a 5-point Likert Scale. Higher scores indicate a higher tendency for that personality trait (1=disagree strongly to 5=agree strongly).
7. Change in testing battery self-report measures in emotional regulation [ Time Frame: Week 1, week 5, and week 9 ]
   Emotion Regulation Questionnaire (ERQ)-10-item scale designed to measure tendency to regulate emotions. Each item is answered on a 7-point Likert Scale (1=strongly disagree to 7=strongly agree). Higher scores indicate a higher emotion regulation strategy.
8. Change in testing battery self-report measures in mindfulness [ Time Frame: Week 1, week 5, and week 9 ]
   Five Facet Mindfulness Questionnaire (FFMQ)-39 item inventory assesses the five facets of mindfulness on a 5-point Likert Scale (1=never or very rarely true and 5=very often or always true). Each facet is tallied and the sum total responses are divided by 39 (number of items). Higher scores indicate higher levels of mindfulness.
9. Change in testing battery self-report measures in sleep quality [ Time Frame: Week 1, week 5, and week 9 ]
   Pittsburgh Sleep Quality Index (PSQI)- 19 item inventory with 7 subjective components that assess sleep quality over time. Each component is scored from 0 to 3 (0=very good and 3=very bad). The sum of the components is the global score and ranges 0-21 (0=no difficulty and 21=severe difficulties). The higher the global score, the poorer the sleep quality.
10. Change in testing battery self-report measures for recovery [ Time Frame: Week 1, week 5, and week 9 ]

    Acute Recovery and Stress Scale (ARSS)- A 32 item inventory that assess subjective measures of physical, mental, and emotional recovery on a 7 point Likert Scale (0=does not apply at all to 6=fully applies). High values in overall recovery indicate feeling physically and mentally recovered. High values in overall stress indicate feeling overloaded and physically tired.

    State-Trait Anxiety Index (STAI)-20 item inventory assesses state and trait anxiety. Values range from 20 to 80, with higher scores representing more severe anxiety.

11. Change in testing battery self-report measures for anxiety [ Time Frame: Week 1, week 5, and week 9 ]
    State-Trait Anxiety Index (STAI)-20 item inventory assesses state and trait anxiety. Values range from 20 to 80, with higher scores representing more severe anxiety.
12. Change in qEEG assessment measures [ Time Frame: Week 1, week 5, and week 9 ]

    The following assessments are used to determine central nervous system function and overall brain health:

    Symptom checklist-150 brief questions; ranking your propensity for traits on 1-7 scale.

    qEEG/ERP assessment-determine central nervous system functional integrity and overall brain health. First half of the assessment will consist of recording two segments in both the eyes-closed and eyes-open condition. Next segment is completed in a series of three sequential measurements, of a bilateral pair of EEG channels. Finally, a 10-minute active auditory task.

13. Change in qEEG questionnaire measures for stress [ Time Frame: Week 1, week 5, and week 9 ]
    Holmes & Rahe Life Stress Inventory- measures amount of stress an individual has experienced within the past year. This scale serves as a control variable; the endorsed events are influencing the individual's current mood, emotions, etc. and in turn their brain function. 43 brief, yes-or-no-type questions.
14. Change in qEEG questionnaire measures [ Time Frame: Week 1, week 5, and week 9 ]
    PERMA-Profiler-measures five pillars: positive emotion, engagement, relationships, meaning, and accomplishment. The measure consists of 23 items rated on an 11-point Likert scale (0= never/not at all; 10= always/completely.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Male or female 18-60 years of age

Exclusion Criteria:

• Weighs more than 250 pounds
• Taller than 76 inches
• 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), immovable splint or brace
• Is claustrophobic (fear of confined spaces)
• Has a skin or respiratory sensitivity or allergy to chlorine, sulfate, magnesium, rubber latex or synthetic latex
• 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 conditions
• Has skin ulcers, open rashes, incisions, stitches or large open wounds that could cause pain when exposed to saltwater
• Has a diagnosis of kidney disease, heart disease or other chronic illness
• Has a 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
• Has a diagnosis of any psychiatric condition (e.g. schizophrenia or bipolar disorder)
• Pregnant or actively trying to become pregnant

Contacts and Locations

Contacts

Contact: Scott Galster, PhD; 304-293-6276; scott.galster@hsc.wvu.edu

Locations

United States, West Virginia

Rockefeller Neuroscience Institute at West Virginia University; Recruiting

Morgantown, West Virginia, United States, 26505

Contact: Scott Galster 304-293-6276 scott.galster@hsc.wvu.edu

Sponsors and Collaborators

West Virginia University

More Information

• Responsible Party: Scott Galster, Director of Applied Research, West Virginia University
• ClinicalTrials.gov Identifier: NCT04628910
• Other Study ID Numbers: 2006024602
• First Posted: November 16, 2020
• Last Update Posted: July 19, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scott Galster, West Virginia University:

Sleep; Sensory Deprivation Tank; Wearable Technology; Dry Float