Sleep QualityNCT04628910
Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
A study testing Simulated Flotation Therapy and Traditional Float-REST Therapy in people with Sleep Quality, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Simulated Flotation Therapy and Traditional Float-REST Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-60 years of age
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- Simulated Flotation Therapy, Traditional Float-REST Therapy
- Keywords
- Sleep, Sensory Deprivation Tank, Wearable Technology, Dry Float
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Flotation TherapyOther
Also called Zerobody Dry Float
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.
Traditional Float-REST TherapyOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Float-REST Therapy | Active comparator | Participants will utilize sensory deprivation tanks. Receives: Other: Traditional Float-REST Therapy |
| Simulated Flotation Therapy | Experimental | Participants will utilize the Zerobody dry flotation therapy. Receives: Other: Simulated Flotation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability as measured by OURA ring
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.
Measured: Daily from baseline through study completion at 9 weeks
Change in heart rate as measured by OURA ring
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.
Measured: Daily from baseline through study completion at 9 weeks
Change in per session self-report measures
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.
Measured: 2 times a week, in 3 week increments, through study completion at 9 weeks
Change in testing battery self-report measures in sleep quality
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.
Measured: Week 1, week 5, and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jul 2020
- Primary completion17 Apr 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628910
- Sponsor's protocol ID
- 2006024602
- Status last verified
- Apr 2025
- First submitted
- 24 Sep 2020
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Differential Effects of Traditional Float-REST and Dry Float on Subjective and Objective Health Outcomes
- ClinicalTrials.gov ID
- NCT04628910
- Acronym / sponsor ID
- 2006024602
- Conditions
- Sleep Quality
- Keywords
- Sleep, Sensory Deprivation Tank, Wearable Technology, Dry Float
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 17 Apr 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Traditional Float-REST Therapy | Active comparator | Other: Traditional Float-REST TherapyParticipants will utilize sensory deprivation tanks. |
| Simulated Flotation Therapy | Experimental | Other: Simulated Flotation TherapyParticipants will utilize the Zerobody dry flotation therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female 18-60 years of age
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated Flotation TherapyAlso: Zerobody Dry FloatThe 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 | Simulated Flotation Therapy |
| Traditional Float-REST TherapyAlso: Sensory Deprivation TanksTraditional 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 | Traditional Float-REST Therapy |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Flotation Therapy and Traditional Float-REST Therapy in people with Sleep Quality, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate variability as measured by OURA ring (time frame: Daily from baseline through study completion at 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.