Sleep QualityNCT05154032
Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery
A study testing Traditional Float-REST Therapy 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 Float-REST affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Traditional Float-REST Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 24 Aug 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-50 years of age
Who cannot join
- Has undergone travel across more than two collective time zones in the last two weeks
- Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
- Has undergone a float-REST session of any kind in the last 3 months
- Has a fresh piercings that is less than 6 weeks old from scheduled session
- Has a fresh tattoo that is less than 4 weeks old from scheduled float
- Has an injury requiring an orthopedic cast (i.e. plaster or synthetic), irremovable splint or brace
Show all 30Show fewer
- Is claustrophobic (fear of confined spaces)
- Has a skin or respiratory sensitivity or allergy to chlorine, sulfate, and/or magnesium
- Has a history of or is prone to motion sickness
- Has had an episode of loss of consciousness in the last 6-months
- Has had a concussion or traumatic brain injury in the last 6-months
- Has a contagious skin condition Has skin ulcers, open rashes, incisions, stiches or large open wounds that could cause pain when exposed to saltwater
- Has an irremovable medical port or catheter
- Has had a seizure in the last 10 years
- Has communicable diseases (e.g. HIV, Hepatitis A, B \& C, tuberculosis, or measles)
- Lack of control of bodily functions prior to scheduled float
- Is pregnant or actively trying to become pregnant
- Has a known or diagnosed sleep disorder
- Females who have become menopausal or are exhibiting signs or symptoms of becoming perimenopausal
- Females who are unable to identify when their monthly menstrual period will occur
- Individuals who work during the night shift or have significantly abnormal sleep schedule
- Individuals who intend to have any significant medical procedures scheduled to occur within 12 weeks of enrollment
- Individuals who have intentions, or have discussed with their doctor, about adding or making any alterations to their prescribed medications within 12 weeks of enrollment
- Individuals who have any travel plans or other obligations within 12 weeks of enrollment that would prevent them from completing study requirements and attending required laboratory visits
- Individuals who intend to make significant alterations to their sleeping patterns within 12 weeks of enrollment. This may include, but is not limited to, changes such as moving, getting a new mattress, having someone move in with them, etc.
- Does not meet the ACSM's guidelines for exercise prescription. This is defined as:
- Presenting with an absolute contraindication OR
- Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
- Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
- presenting with two or more relative contraindications
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 Float-REST affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.
Read the detailed description
Traditional flotation therapy (Float-REST; Flotation Restricted Environmental Stimulation Therapy) uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant 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. Previous studies have examined the effects of sensory-deprivation tanks on both subjective (e.g., perceived stress and anxiety, self-reported muscle soreness) and objective measures of recovery (e.g., blood pressure, skill performance) though findings are incomplete and contradictory. Additionally, provided the growing understanding that sleep quality and quantity are at the forefront of ensuring optimal human performance states, compounded by the deleterious effects of high stress and anxiety on sleep, utilizing flotation therapy as a mechanism for enhancing sleep requires further investigation.
To identify whether Float-REST influences sleep and related behaviors, an eight week design will be executed that comprises an initial four weeks of baseline data collections followed by four weeks of intervention application and measure. Intervention will consist of three 60 minute Float-REST sessions per week, for the first three weeks of the intervention block (weeks 5-7 of the study). Data measures include wearable device monitoring, surveys, and brief cognitive tasks that are collected at various timepoints throughout the study (intake, monthly, weekly, daily, etc.).
- Conditions
- Sleep Quality
- Being tested
- Traditional Float-REST Therapy
- 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.
Traditional Float-REST TherapyOther
Also called Sensory Deprivation Tanks
Traditional Float-REST therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant 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. The room will contain an intercom that allows participants to communicate with study personnel in the event they need assistance. Participants will undergo 60 minute sessions three times a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Float-REST Therapy | Experimental | Participants will utilize sensory deprivation tanks. Receives: Other: Traditional Float-REST Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nocturnal Heart Rate as measured by OURA Ring
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Measured: Daily from baseline through study completion at 8 weeks
Change in Sleep Quantity as measured by Electroencephalography
Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses Electroencephalography (EEG) for automatic sleep stage scoring.
Measured: Daily from baseline through study completion at 8 weeks
Change in Subjective Sleep Quality
A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.
Measured: Daily from baseline through study completion at 8 weeks
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Heart rate variability will be quantified throughout the night via the OURA ring.
Measured: Daily from baseline through study completion at 8 weeks
Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index
Participants will complete the previously validated State Trait Anxiety Index (STAI) before and after each float session as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety.
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 complete the STAI questionnaire before and after each session. The sessions will take place during weeks 5-7.
Measured: Before and after each float session (Weeks 5-7)
Change in heart rate during Float-REST as measured via Electrocardiography
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Measured: During each float session (weeks 5-7)
Change in heart rate variability during Float-REST as measured via Electrocardiography
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Measured: During each float session (weeks 5-7)
Secondary outcomes (17)
Change in Subjective Athens Insomnia Scale measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks).
Athens Insomnia Scale (AIS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = greater difficulty.
Measured: Weekly throughout study completion at 8 weeks
Change in Subjective Epworth Sleepiness Scale measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks).
Epworth Sleepiness Scale (ESS) - eight-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased average sleep propensity in daily life
Measured: Weekly throughout study completion at 8 weeks
Change in Subjective Insomnia Severity Index measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks).
Insomnia Severity Index (ISI) - seven-item questionnaire assessing sleep behaviors on a scale of 0 to 3. Higher scores = increased severity.
Measured: Weekly throughout study completion at 8 weeks
Change in Subjective Restorative Sleep Questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks).
Restorative Sleep Questionnaire (RSQ) - nine-item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = better sleep
Measured: Weekly throughout study completion at 8 weeks
Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire
Participants will complete previously validated questionnaires as often as once weekly throughout the study period (8 weeks).
Patient Reported Outcomes Measurement Information System (PROMIS) - seven item questionnaire assessing sleep behaviors on a scale of 0 to 5. Higher scores = healthier subject
Measured: Weekly throughout study completion at 8 weeks
Subjective Sleep Preferences
At intake, a custom baseline questionnaire will be completed to record each participants sleep preferences and common behaviors. These sleep preferences will be used to identify if Float-REST tends to be more or less successful for certain individuals based upon predetermined qualities.
Measured: Once at the beginning of week 1
Subjective Success of Float-REST
Following completion of the study, a custom questionnaire will record how successful the participant believes Float-REST was for improving their sleep and well-being. Participants will indicate how much they relate to a particular item on a scale of "Not at all" to "Very much so"
Measured: Once at the end of week 8
Changes in Conflict Management via Questionnaire
Participants ability to manage conflict and the strategies in which they approach conflict will be assessed via the Conflict Management Questionnaire. This questionnaire scores the management of various situations based upon the participant responses (definitely true, true, tends to be true, tends not to be true, not true, definitely not true) and classifies the highest scoring response category as being the participant's preferred method of handing conflict. Scores of the response categories will be compared.
Measured: Monthly from baseline through study completion at 8 weeks
Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire
Participants' ability to regulate their emotions appropriately will be quantified via the previously validated Emotional Regulation Questionnaire (ERQ), in which participants will indicate how much they agree with each statement (1, strongly disagree; 7, strongly agree).
Measured: Monthly from baseline through study completion at 8 weeks
Changes in Perceived Stress as measured via Perceived Stress Scale
Participants' perceived stress will be quantified via the previously validated Perceived Stress Scale (PSS), which asks participants to report on the frequency of various experiences (0, never; 4, very often) and final scoring suggests lower scores to be associated with lower levels of stress.
Measured: Weekly from baseline through study completion at 8 weeks
Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index
Participant's subjective reports of sleep quality will be quantified through the previously validated Pittsburgh Sleep Quality Index (PSQI). Questions are scored into multiple components to determine sleep difficulty in various areas, where higher scores are indicative of greater sleep difficulties; these scores will be compared across timepoints.
Measured: Monthly from baseline through study completion at 8 weeks
Changes in Subjective Anxiety as measured via the State Trait Anxiety Index
Participants will complete the previously validated State Trait Anxiety Index (STAI) as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety.
Measured: Monthly from baseline through study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Participants will complete a 34 item checklist that has been previously used for screening of a potential sleep disorder; the more items that the participant feels applies to them, the higher the likelihood of the individual having a sleep disorder.
Measured: Monthly from baseline through study completion at 8 weeks
Change in Cognitive Performance via Stroop Task
Participants will complete the Stroop Task at intake and once weekly throughout the study on a computer. The task requires participants to respond to the presentation of a word by clicking the key associated with the ink color rather than the meaning of the word. Participants will be monitored for speed and accuracy of responses.
Measured: Weekly from baseline through study completion at 8 weeks.
Change in Response Inhibition via SART 2
Participants will complete the SART 2 task at intake and once weekly throughout the study on a computer. The task requires participants to respond, or refrain from responding, to the presentation of a number; a predetermined number is provided at the start of the task that participants are asked to refrain from responding to. Participants will be monitored for speed and accuracy of responses.
Measured: Weekly from baseline through study completion at 8 weeks.
Change in Attentional Vigilance via Mackworth Clock Task
Participants will complete the Mackworth Clock task at intake and once weekly throughout the study on a computer. The task requires participants to watch the second hand of a clock across five minutes and respond as quickly as possible to skips in the clock's second hand by pressing a key. Participants will be monitored throughout the task for speed and accuracy of responses.
Measured: Weekly from baseline through study completion at 8 weeks.
Change in Mental Rotation via Computer Task
Participants will complete the Mental Rotation task at intake and once monthly throughout the study on a computer. The task requires participants to respond as quickly as possible by select from two pictures that accurately depicts the same object that is presented in a different position in a third picture. 10 warm up trials will be completed followed by 10 test trials. Participants will be monitored throughout the task for speed and accuracy of responses.
Measured: Monthly from baseline 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 posted10 Dec 2021
- Study start2 Nov 2021
- Primary completion1 Nov 2022
- Study completion24 Aug 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.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete the following design. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 and 8 for consistency. Baseline block (weeks 1-4): At intake, participants will complete up to 13 surveys, which includes two baseline questionnaires, \& the first rendition of weekly and monthly surveys. Participants will complete daily surveys each morning \& night, \& wear wearable devices to monitor physiology during sleep. Additionally, a laboratory visit will occur once per week for completion of weekly surveys \& cognitive assessments; monthly surveys will also be completed during the fourth week. Intervention block (weeks 5-8): Daily, weekly, \& monthly activities described for the baseline block will continue. Additionally, during weeks 5-7, participants will complete three 60-minute Float-REST sessions per week; The final week of this block will only involve the daily, weekly \& monthly activities plus an exit survey.
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT05154032
- Sponsor's protocol ID
- 2104298113
- Status last verified
- Apr 2025
- First submitted
- 24 Sep 2021
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Differential Effects of Traditional Float-REST on Sleep and Recovery
- ClinicalTrials.gov ID
- NCT05154032
- Acronym / sponsor ID
- 2104298113
- Conditions
- Sleep Quality
- Keywords
- Sleep, Sensory Deprivation Tank, Wearable Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 10 Dec 2021 (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 Float-REST affects sleep quality, sleep structure, nocturnal physiology, subjective wellness, recovery from stressors, and resultant effects on performance and well-being.
Detailed description
Traditional flotation therapy (Float-REST; Flotation Restricted Environmental Stimulation Therapy) uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant 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. Previous studies have examined the effects of sensory-deprivation tanks on both subjective (e.g., perceived stress and anxiety, self-reported muscle soreness) and objective measures of recovery (e.g., blood pressure, skill performance) though findings are incomplete and contradictory. Additionally, provided the growing understanding that sleep quality and quantity are at the forefront of ensuring optimal human performance states, compounded by the deleterious effects of high stress and anxiety on sleep, utilizing flotation therapy as a mechanism for enhancing sleep requires further investigation.
To identify whether Float-REST influences sleep and related behaviors, an eight week design will be executed that comprises an initial four weeks of baseline data collections followed by four weeks of intervention application and measure. Intervention will consist of three 60 minute Float-REST sessions per week, for the first three weeks of the intervention block (weeks 5-7 of the study). Data measures include wearable device monitoring, surveys, and brief cognitive tasks that are collected at various timepoints throughout the study (intake, monthly, weekly, daily, etc.).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete the following design. Women who experience menstrual flow will be scheduled to ensure that flow occurs on weeks 4 and 8 for consistency. Baseline block (weeks 1-4): At intake, participants will complete up to 13 surveys, which includes two baseline questionnaires, \& the first rendition of weekly and monthly surveys. Participants will complete daily surveys each morning \& night, \& wear wearable devices to monitor physiology during sleep. Additionally, a laboratory visit will occur once per week for completion of weekly surveys \& cognitive assessments; monthly surveys will also be completed during the fourth week. Intervention block (weeks 5-8): Daily, weekly, \& monthly activities described for the baseline block will continue. Additionally, during weeks 5-7, participants will complete three 60-minute Float-REST sessions per week; The final week of this block will only involve the daily, weekly \& monthly activities plus an exit survey.
| Arm | Type | Receives |
|---|---|---|
| Traditional Float-REST Therapy | Experimental | Other: Traditional Float-REST TherapyParticipants will utilize sensory deprivation tanks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female 18-50 years of age
Key exclusion criteria (30 listed)
- Has undergone travel across more than two collective time zones in the last two weeks
- Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
- Has undergone a float-REST session of any kind in the last 3 months
- Has a fresh piercings that is less than 6 weeks old from scheduled session
- Has a fresh tattoo that is less than 4 weeks old from scheduled float
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 |
|---|---|---|
| Traditional Float-REST TherapyAlso: Sensory Deprivation TanksTraditional Float-REST therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant 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. The room will contain an intercom that allows participants to communicate with study personnel in the event they need assistance. Participants will undergo 60 minute sessions three times a week for 3 weeks. | Other | Traditional Float-REST Therapy |
Primary outcome
Change in Nocturnal Heart Rate as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in Sleep Quantity as measured by Electroencephalography
Time frame: Daily from baseline through study completion at 8 weeks
Sleep stage duration (and the cumulative sleep duration) will be quantified each night via the Dreem headband, which uses Electroencephalography (EEG) for automatic sleep stage scoring.
Change in Subjective Sleep Quality
Time frame: Daily from baseline through study completion at 8 weeks
A custom daily morning questionnaire will be used to record how a participant feels the quality of their sleep was the previous night (e.g. 1, very poor; 10 excellent). This questionnaire will be taken on the participants smartphone within 30 minutes of waking.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Heart rate variability will be quantified throughout the night via the OURA ring.
Change in Anxiety surrounding Float-REST as measured by the State Trait Anxiety Index
Time frame: Before and after each float session (Weeks 5-7)
Participants will complete the previously validated State Trait Anxiety Index (STAI) before and after each float session as a measure of subjective anxiety, where higher scores are suggestive of greater anxiety. 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 complete the STAI questionnaire before and after each session. The sessions will take place during weeks 5-7.
Change in heart rate during Float-REST as measured via Electrocardiography
Time frame: During each float session (weeks 5-7)
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
Change in heart rate variability during Float-REST as measured via Electrocardiography
Time frame: During each float session (weeks 5-7)
Participants will be monitored throughout float sessions using a heart rate monitor that will capture trends in cardiovascular physiology throughout the session.
17 secondary outcomes
Change in Subjective Athens Insomnia Scale measured via questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Epworth Sleepiness Scale measured via questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Insomnia Severity Index measured via questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Restorative Sleep Questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Change in Subjective Patient Reported Outcomes Measurement Information System measured via questionnaire
Time frame: Weekly throughout study completion at 8 weeks
Subjective Sleep Preferences
Time frame: Once at the beginning of week 1
Subjective Success of Float-REST
Time frame: Once at the end of week 8
Changes in Conflict Management via Questionnaire
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Emotional Regulation as measured via Emotional Regulation Questionnaire
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Perceived Stress as measured via Perceived Stress Scale
Time frame: Weekly from baseline through study completion at 8 weeks
Changes in Subjective Sleep as measured via Pittsburgh Sleep Quality Index
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Subjective Anxiety as measured via the State Trait Anxiety Index
Time frame: Monthly from baseline through study completion at 8 weeks
Changes in Sleep Disturbances as measured via the Sleep Disorders Questionnaire
Time frame: Monthly from baseline through study completion at 8 weeks
Change in Cognitive Performance via Stroop Task
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Response Inhibition via SART 2
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Attentional Vigilance via Mackworth Clock Task
Time frame: Weekly from baseline through study completion at 8 weeks.
Change in Mental Rotation via Computer Task
Time frame: Monthly from baseline through study completion at 8 weeks.
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 25 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 Traditional Float-REST Therapy 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 30 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 25 Apr 2025. 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 Nocturnal Heart Rate as measured by OURA Ring (time frame: Daily from baseline through study completion at 8 weeks). The study lists 7 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 25 Apr 2025.