- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628910
Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Virginia
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Morgantown, West Virginia, United States, 26505
- Rockefeller Neuroscience Institute at West Virginia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Float-REST Therapy
Participants will utilize sensory deprivation tanks.
|
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 Names:
|
|
Experimental: Simulated Flotation Therapy
Participants will utilize the Zerobody dry 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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2 times a week, in 3 week increments, through study completion at 9 weeks
|
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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.
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Week 1, week 5, and week 9
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Change in heart rate variability 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.
Heart rate variability will be quantified throughout the night via the OURA ring.
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Daily from baseline through study completion at 9 weeks
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Change in heart rate 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.
Heart rate will be quantified throughout the night via the OURA ring.
|
Daily from baseline through study completion at 9 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006024602
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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