Clinical trial NCT04415970: Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery
Official title: Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Sleep
Sensory deprivation tank
Wearable technology
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in sleep patterns
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in self-report measures
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change from baseline in self-report measures
timeFrame: At baseline, at 8 weeks
measure: Change in monthly self-report measures
timeFrame: At baseline, at 4 weeks, at 8 weeks
measure: Change in per session self-report measures
timeFrame: 2 times a week through study completion at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
References: