Sleep QualityNCT04415970
Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery
A study testing Flotation therapy sensory deprivation tank and Sleep Pod in people with Sleep Quality, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Flotation therapy sensory deprivation tank and Sleep Pod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- Flotation therapy sensory deprivation tank, Sleep Pod
- Keywords
- Sleep, Sensory deprivation tank, Wearable technology
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotation therapy sensory deprivation tankOther
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 PodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Flotation Therapy | Experimental | Participants will utilize flotation sensory deprivation tanks. Receives: Other: Flotation therapy sensory deprivation tank |
| Sleep Pod | Active comparator | Participants will utilize sleep pods with partial sensory deprivation (no light and silence). Receives: Other: Sleep Pod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep patterns
The OURA Rings is a commercially available wearable device that continuously monitors sleep and sleep quality.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 times a week through study completion at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start10 Jan 2020
- Primary completion1 May 2021
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415970
- Sponsor's protocol ID
- 1910751767
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery
- ClinicalTrials.gov ID
- NCT04415970
- Acronym / sponsor ID
- 1910751767
- Conditions
- Sleep Quality
- Keywords
- Sleep, Sensory deprivation tank, Wearable technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Flotation Therapy | Experimental | Other: Flotation therapy sensory deprivation tankParticipants will utilize flotation sensory deprivation tanks. |
| Sleep Pod | Active comparator | Other: Sleep PodParticipants will utilize sleep pods with partial sensory deprivation (no light and silence). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female 18 years of age or older
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flotation therapy sensory deprivation tankParticipants 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. | Other | Flotation Therapy |
| Sleep PodParticipants 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. | Other | Sleep Pod |
Primary outcome
Change in sleep patterns
Time frame: Daily from baseline through study completion at 8 weeks
The OURA Rings is a commercially available wearable device that continuously monitors sleep and sleep quality.
Change in self-report measures
Time frame: Daily from baseline through study completion at 8 weeks
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).
Change from baseline in self-report measures
Time frame: At baseline, at 8 weeks
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.
Change in monthly self-report measures
Time frame: At baseline, at 4 weeks, at 8 weeks
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.
Change in per session self-report measures
Time frame: 2 times a week through study completion at 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flotation therapy sensory deprivation tank and Sleep Pod in people with Sleep Quality, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep patterns (time frame: Daily from baseline through study completion at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.