NCT04628910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 28, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

September 24, 2020

Last Update Submit

August 21, 2025

Conditions

Keywords

SleepSensory Deprivation TankWearable TechnologyDry Float

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Week 1, week 5, and week 9

Study Arms (2)

Traditional Float-REST Therapy

ACTIVE COMPARATOR

Participants will utilize sensory deprivation tanks.

Other: Traditional Float-REST Therapy

Simulated Flotation Therapy

EXPERIMENTAL

Participants will utilize the Zerobody dry flotation therapy.

Other: Simulated Flotation Therapy

Interventions

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.

Also known as: Zerobody Dry Float
Simulated Flotation 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.

Also known as: Sensory Deprivation Tanks
Traditional Float-REST Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female 18-60 years of age

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

November 16, 2020

Study Start

July 1, 2020

Primary Completion

April 17, 2022

Study Completion

October 31, 2023

Last Updated

August 28, 2025

Record last verified: 2025-04

Locations