Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery

The objective of this research study is to assess how the implementation of various modern strategies for augmented recovery and physiological monitoring via wearable biotechnologies and subjective measurements affect sleep quality, and other indices of recovery from physical activity.

Study Overview

• Status: Completed
• Conditions: Sleep Quality
• Intervention / Treatment: Other: Flotation therapy sensory deprivation tank; Other: Sleep Pod

Detailed Description

Flotation therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salts to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the subject 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. To control for potential changes in sleep quality, quantity, and/or stress and anxiety, a control condition utilizing a Metronap nap station to ascertain the effects of standard, horizontal napping with partial sensory deprivation (no light and silence) compared with floating.

To assess whether or not flotation therapy positively influences sleep and perceptual recovery, participants will float for 60 minutes 2 times a week for 8 weeks, use the sleep pod for 60 minutes 2 times a week for 8 weeks, or take part in a cross-over study where the participant will alternate float and sleep pod every 2 weeks for 8 weeks. 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, monthly, and pre/post-study questionnaires will be submitted via a smartphone application.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Hagan, PhD; Phone Number: 304-293-4816; Email: joshua.hagen@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Rockefeller Neuroscience Institute at West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female 18 years of age or older

Exclusion Criteria:

• Do not have any contagious skin infections or diseases
• Do not have a history of seizures
• Do not have a history of being prone to motion sickness
• An episode of loss of consciousness (last 6-months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flotation Therapy; Participants will utilize flotation sensory deprivation tanks.	Other: Flotation therapy sensory deprivation tank; Participants will float for 60 minutes, 2 times a week for 8 consecutive weeks or alternate with sleep pod every 2 weeks for 8 weeks. All participants will wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. Each session will be preceded by a short safety questionnaire and an anxiety index. Following each session, the participant will complete the index again. Participants will also complete morning and evening questionnaires and monthly questionnaires on a smartphone.
Active Comparator: Sleep Pod; Participants will utilize sleep pods with partial sensory deprivation (no light and silence).	Other: Sleep Pod; Participants will utilize the sleep pod for 60 minutes, 2 times a week for 8 consecutive weeks or alternate with float every 2 weeks for 8 weeks. All participants will wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. Each session will be preceded by a short anxiety index. Following each session, the participant will complete the index again. Participants will also complete morning and evening questionnaires and monthly questionnaires on a smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep patterns	The OURA Rings is a commercially available wearable device that continuously monitors sleep and sleep quality.	Daily from baseline through study completion at 8 weeks
Change in self-report measures	Short Recovery and Stress Scale (SRSS)-An 8 item inventory that assess subjective measures of physical, mental, and emotional recovery on a 7 point Likert Scale (0=does not apply at all to 6=fully applies). High values in overall recovery indicate feeling physically and mentally recovered. High values in overall stress indicate feeling overloaded and physically tired. End of Day Questionnaire (EoD)-Developed at the Rockefeller Neuroscience Institute (RNI) as a modification of the NASA Task Load Index. This questionnaire addresses subjective measures of workload and stressors that were encountered throughout the day. Post-Training Rating of Perceived Exertion Questionnaire-An adaption of the Borg Rating of Perceived Exertion scale, commonly referred to as RPE. The questionnaire requires participants to list the specific activity and the subjective measure of exercise intensity. The scale ranges from 6-20 (6=no exertion that is equivalent to rest and 20=maximal exertion).	Daily from baseline through study completion at 8 weeks
Change from baseline in self-report measures	Big Five Inventory (BFI)-44 item inventory designed to measure the Big Five Factors of personality on a 5-point Likert Scale. Higher scores indicate a higher tendency for that personality trait (1=disagree strongly to 5=agree strongly). Emotion Regulation Questionnaire (ERQ)-10-item scale designed to measure tendency to regulate emotions. Each item is answered on a 7-point Likert Scale (1=strongly disagree to 7=strongly agree). Higher scores indicate a higher emotion regulation strategy. Five Facet Mindfulness Questionnaire (FFMQ)-39 item inventory assesses the five facets of mindfulness on a 5-point Likert Scale (1=never or very rarely true and 5=very often or always true). Each facet is tallied and the sum total responses are divided by 39 (number of items). Higher scores indicate higher levels of mindfulness. State-Trait Anxiety Index (STAI)-20 item inventory assesses state and trait anxiety. Values range from 20 to 80, with higher scores representing more severe anxiety.	At baseline, at 8 weeks
Change in monthly self-report measures	Acute Recovery and Stress Scale (ARSS)- A 32 item inventory that assess subjective measures of physical, mental, and emotional recovery on a 7 point Likert Scale (0=does not apply at all to 6=fully applies). High values in overall recovery indicate feeling physically and mentally recovered. High values in overall stress indicate feeling overloaded and physically tired. 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.	At baseline, at 4 weeks, at 8 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 take the STAI questionnaire before and after each intervention session.	2 times a week through study completion at 8 weeks

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Sensory deprivation tank; Wearable technology
• Other Study ID Numbers: 1910751767

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No