Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery

NCT05154032 | Completed

• 1 other identifier: 2104298113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research study is to assess how the implementation of Float-REST affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.

Conditions

Sleep Quality

Keywords

Sleep; Sensory Deprivation Tank; Wearable Technology

Outcome Measures

Primary Outcomes (7)

• Change in Nocturnal Heart Rate as measured by OURA Ring

  Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.

  Daily from baseline through study completion at 8 weeks

• Change in Sleep Quantity as measured by Electroencephalography

  Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses Electroencephalography (EEG) for automatic sleep stage scoring.

  Daily from baseline through study completion at 8 weeks

• Change in Subjective Sleep Quality

  A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.

  Daily from baseline through study completion at 8 weeks

• Change in Nocturnal Heart Rate Variability as measured by OURA Ring

  Heart rate variability will be quantified throughout the night via the OURA ring.

  Daily from baseline through study completion at 8 weeks

• Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index

  Participants will complete the previously validated State Trait Anxiety Index (STAI) before and after each float session as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety. 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. The sessions will take place during weeks 5-7.

  Before and after each float session (Weeks 5-7)

• Change in heart rate during Float-REST as measured via Electrocardiography

  Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.

  During each float session (weeks 5-7)

• Change in heart rate variability during Float-REST as measured via Electrocardiography

  Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.

  During each float session (weeks 5-7)

Secondary Outcomes (17)

• Change in Subjective Athens Insomnia Scale measured via questionnaire

  Weekly throughout study completion at 8 weeks

• Change in Subjective Epworth Sleepiness Scale measured via questionnaire

  Weekly throughout study completion at 8 weeks

• Change in Subjective Insomnia Severity Index measured via questionnaire

  Weekly throughout study completion at 8 weeks

• Change in Subjective Restorative Sleep Questionnaire

  Weekly throughout study completion at 8 weeks

• Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire

  Weekly throughout study completion at 8 weeks

Study Arms (1)

Traditional Float-REST Therapy

EXPERIMENTAL

Participants will utilize sensory deprivation tanks.

Other: Traditional Float-REST Therapy

Interventions

Traditional Float-REST Therapy OTHER

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 three times a week for 3 weeks.

Also known as: Sensory Deprivation Tanks

Traditional Float-REST Therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18-50 years of age

You may not qualify if:

• Has undergone travel across more than two collective time zones in the last two weeks
• Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
• 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), irremovable splint or brace
• Is claustrophobic (fear of confined spaces)
• Has a skin or respiratory sensitivity or allergy to chlorine, sulfate, and/or magnesium
• 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 condition Has skin ulcers, open rashes, incisions, stiches or large open wounds that could cause pain when exposed to saltwater
• Has an 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)

Sponsors & Collaborators

• West Virginia University: lead

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, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete the following design. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 and 8 for consistency. Baseline block (weeks 1-4): At intake, participants will complete up to 13 surveys, which includes two baseline questionnaires, \& the first rendition of weekly and monthly surveys. Participants will complete daily surveys each morning \& night, \& wear wearable devices to monitor physiology during sleep. Additionally, a laboratory visit will occur once per week for completion of weekly surveys \& cognitive assessments; monthly surveys will also be completed during the fourth week. Intervention block (weeks 5-8): Daily, weekly, \& monthly activities described for the baseline block will continue. Additionally, during weeks 5-7, participants will complete three 60-minute Float-REST sessions per week; The final week of this block will only involve the daily, weekly \& monthly activities plus an exit survey.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: December 10, 2021
• Study Start: November 2, 2021
• Primary Completion: November 1, 2022
• Study Completion: August 24, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (1)