Clinical trial NCT04628910: Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
Official title: Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep Quality
Keywords: Sleep
Sensory Deprivation Tank
Wearable Technology
Dry Float
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in sleep patterns as measured by OURA ring
timeFrame: Daily from baseline through study completion at 9 weeks
measure: Change in daily self-report measures for recovery
timeFrame: Daily from baseline through study completion at 9 weeks
measure: Change in daily self-report measures for task load
timeFrame: Daily from baseline through study completion at 9 weeks
measure: Change in daily self-report measures in perceived exertion
timeFrame: Daily from baseline through study completion at 9 weeks
measure: Change in per session self-report measures
timeFrame: 2 times a week, in 3 week increments, through study completion at 9 weeks
measure: Change in testing battery self-report measures in personality
timeFrame: Week 1, week 5, and week 9
measure: Change in testing battery self-report measures in emotional regulation
timeFrame: Week 1, week 5, and week 9
measure: Change in testing battery self-report measures in mindfulness
timeFrame: Week 1, week 5, and week 9
measure: Change in testing battery self-report measures in sleep quality
timeFrame: Week 1, week 5, and week 9
measure: Change in testing battery self-report measures for recovery
timeFrame: Week 1, week 5, and week 9
measure: Change in testing battery self-report measures for anxiety
timeFrame: Week 1, week 5, and week 9
measure: Change in qEEG assessment measures
timeFrame: Week 1, week 5, and week 9
measure: Change in qEEG questionnaire measures for stress
timeFrame: Week 1, week 5, and week 9
measure: Change in qEEG questionnaire measures
timeFrame: Week 1, week 5, and week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: