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

NCT ID: NCT04415970

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2023-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Flotation Therapy

Participants will utilize flotation sensory deprivation tanks.

Group Type EXPERIMENTAL

Flotation therapy sensory deprivation tank

Intervention Type 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.

Sleep Pod

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

Group Type ACTIVE_COMPARATOR

Sleep Pod

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1910751767

Identifier Type: -

Identifier Source: org_study_id

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