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

NCT04415970 | Completed

• 1 other identifier: 1910751767
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Quality

Keywords

Sleep; Sensory deprivation tank; Wearable technology

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Flotation Therapy

EXPERIMENTAL

Participants will utilize flotation sensory deprivation tanks.

Other: Flotation therapy sensory deprivation tank

Sleep Pod

ACTIVE COMPARATOR

Participants will utilize sleep pods with partial sensory deprivation (no light and silence).

Other: Sleep Pod

Interventions

Flotation therapy sensory deprivation tank OTHER

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.

Flotation Therapy

Sleep Pod OTHER

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.

Sleep Pod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 years of age or older

You may not qualify if:

• 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)

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: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We aim to assign participants into one of two different sub-study designs: 1. Group A: Participants will float for 60 minutes, 2 times a week for 8 weeks or use the sleep pod for 60 minutes, 2 times a week for 8 weeks. 2. Group B: Participants will engage in a crossover design in which they will participate in both float and nap pod, each for two weeks at a time, twice. The order in which these participants engage in the two recovery modalities will be randomly assigned via statistical package R. The only difference between Groups A and B is how often/frequent they engage in the two different modalities. Participants in group A will only do float or Metronap - participants in Group B will do both and alternate every two weeks.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: June 4, 2020
• Study Start: January 10, 2020
• Primary Completion: May 1, 2021
• Study Completion: February 15, 2023
• Last Updated: March 7, 2024

Record last verified: 2023-04

Locations

US (1)