AnxietyNCT02452203
Examining the Effects of Reduced Environmental Stimulation on the Brain
A study testing Floating in people with Anxiety, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Floating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 31 Dec 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between 18-55 years of age, free of any current or past neurological or psychiatric illness, and capable of performing all tasks during each session of the experiment.
- They must be able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
Who cannot join
- Participant meets criteria for a DSM5 Axis-1 disorder.
- Participant endorses current suicidal ideation with intent or plan.
- Participant fails to adhere to our "Pre-float checklist".
- Participant is morbidly obese (BMI > 40).
- Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., benzodiazepines, opiates, selective serotonin reuptake inhibitors, dopamine agonists, barbiturates, MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine). For all other medications, we require the participant to be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
- Participant has a history of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
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- Pregnancy as detected by a urine test.
- Non-correctable vision or hearing problems.
- MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/ wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Read the detailed description
The human brain is constantly bombarded with sensory information from the external world. This series of studies aim to explore the effects of reducing environmental stimulation using specially designed floatation pools that minimize visual, auditory, tactile, proprioceptive, and thermal input to the brain. Previous research has shown that "floating" in this unique setting can significantly reduce levels of anxiety, stress, blood pressure, and cortisol, while significantly increasing levels of both subjective and physiological forms of relaxation. Much of this past research contained various methodological weaknesses, including small sample sizes, lack of a control group, and no longitudinal follow-up. Moreover, very little is known about the potential benefits of floating in clinical populations, and essentially nothing is known about the effects of floating on the brain. The studies proposed in this protocol aim to further explore floating's potentially salubrious effect on the autonomic nervous system, while beginning to investigate its largely unknown effect on the central nervous system. The researchers have attempted to improve upon the weaknesses of past research by using larger sample sizes, a control group, and a longitudinal design. The current project is focused on documenting the subjective, behavioral, physiological and neural effects of floating in healthy and anxious populations. The subjective effects of floating will be examined using self-report measures and the experience sampling method. The behavioral effects of floating will be examined using measures of interoceptive awareness and distress tolerance. The physiological effects of floating will be examined using waterproof and wireless tracking of blood pressure, heart rate, respiration, and movement, in addition to collecting measures of cortisol and magnesium. A portable electroencephalography (EEG) system will be used to measure sleep during the nights before and after a float experience. The neural effects of floating will be examined using waterproof and wireless EEG collected during the float experience, as well as using functional magnetic resonance imaging (fMRI) collected before and immediately after floating. Using a longitudinal within-subject design, the researchers have a unique opportunity to assess not only functional brain changes, but also structural brain changes induced by repeated exposures to floating. An active control condition aims to control for the effects of simple relaxation by collecting all of the same measures while participants lay supine in a zero-gravity chair situated in a quiet, dimly lit room. This program of research constitutes the first systematic investigation of floating on the body and the brain, and the findings have the potential to illuminate the physiological and neural correlates of the deep relaxation induced by the floating experience.
- Conditions
- Anxiety
- Being tested
- Floating
- Keywords
- floating, interoception
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloatingBehavioural
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
| Study group | Role | What they receive |
|---|---|---|
| Floating | Experimental | The participant will float supine in water with a high concentration of Epsom salt for 90 minutes. Receives: Behavioral: Floating |
| Chair | Placebo comparator | The participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes. Receives: Behavioral: Floating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
MRI scan to measure the blood flow changes in the brain
Measured: fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Feinstein, Laureate Institute for Brain Research, Inc.
- Investigators
- Justin Feinstein, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452203
- Sponsor's protocol ID
- float-fMRI-1
- Status last verified
- Sep 2020
- First submitted
- 18 May 2015
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Al Zoubi O, Misaki M, Bodurka J, Kuplicki R, Wohlrab C, Schoenhals WA, Refai HH, Khalsa SS, Stein MB, Paulus MP, Feinstein JS. Taking the body off the mind: Decreased functional connectivity between somatomotor and default-mode networks following Floatation-REST. Hum Brain Mapp. 2021 Jul;42(10):3216-3227. doi: 10.1002/hbm.25429. Epub 2021 Apr 9.
PubMed 33835628
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Reduced Environmental Stimulation on the Brain
- ClinicalTrials.gov ID
- NCT02452203
- Acronym / sponsor ID
- float-fMRI-1
- Conditions
- Anxiety
- Keywords
- floating, interoception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 May 2015 (estimated)
- 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 studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Detailed description
The human brain is constantly bombarded with sensory information from the external world. This series of studies aim to explore the effects of reducing environmental stimulation using specially designed floatation pools that minimize visual, auditory, tactile, proprioceptive, and thermal input to the brain. Previous research has shown that "floating" in this unique setting can significantly reduce levels of anxiety, stress, blood pressure, and cortisol, while significantly increasing levels of both subjective and physiological forms of relaxation. Much of this past research contained various methodological weaknesses, including small sample sizes, lack of a control group, and no longitudinal follow-up. Moreover, very little is known about the potential benefits of floating in clinical populations, and essentially nothing is known about the effects of floating on the brain. The studies proposed in this protocol aim to further explore floating's potentially salubrious effect on the autonomic nervous system, while beginning to investigate its largely unknown effect on the central nervous system. The researchers have attempted to improve upon the weaknesses of past research by using larger sample sizes, a control group, and a longitudinal design. The current project is focused on documenting the subjective, behavioral, physiological and neural effects of floating in healthy and anxious populations. The subjective effects of floating will be examined using self-report measures and the experience sampling method. The behavioral effects of floating will be examined using measures of interoceptive awareness and distress tolerance. The physiological effects of floating will be examined using waterproof and wireless tracking of blood pressure, heart rate, respiration, and movement, in addition to collecting measures of cortisol and magnesium. A portable electroencephalography (EEG) system will be used to measure sleep during the nights before and after a float experience. The neural effects of floating will be examined using waterproof and wireless EEG collected during the float experience, as well as using functional magnetic resonance imaging (fMRI) collected before and immediately after floating. Using a longitudinal within-subject design, the researchers have a unique opportunity to assess not only functional brain changes, but also structural brain changes induced by repeated exposures to floating. An active control condition aims to control for the effects of simple relaxation by collecting all of the same measures while participants lay supine in a zero-gravity chair situated in a quiet, dimly lit room. This program of research constitutes the first systematic investigation of floating on the body and the brain, and the findings have the potential to illuminate the physiological and neural correlates of the deep relaxation induced by the floating experience.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floating | Experimental | Behavioral: FloatingThe participant will float supine in water with a high concentration of Epsom salt for 90 minutes. |
| Chair | Placebo comparator | Behavioral: FloatingThe participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be between 18-55 years of age, free of any current or past neurological or psychiatric illness, and capable of performing all tasks during each session of the experiment.
- They must be able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
Key exclusion criteria (9 listed)
- Participant meets criteria for a DSM5 Axis-1 disorder.
- Participant endorses current suicidal ideation with intent or plan.
- Participant fails to adhere to our "Pre-float checklist".
- Participant is morbidly obese (BMI > 40).
- Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., benzodiazepines, opiates, selective serotonin reuptake inhibitors, dopamine agonists, barbiturates, MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine). For all other medications, we require the participant to be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
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 |
|---|---|---|
| FloatingFloating in either a pool saturated with Epsom salt or in a zero-gravity chair | Behavioural | Chair, Floating |
Primary outcome
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
Time frame: fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks
MRI scan to measure the blood flow changes in the brain
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 22 Sep 2020.
- Derived from this study: PubMed 33835628Al Zoubi O, Misaki M, Bodurka J, Kuplicki R, Wohlrab C, Schoenhals WA, Refai HH, Khalsa SS, Stein MB, Paulus MP, Feinstein JS. Taking the body off the mind: Decreased functional connectivity between somatomotor and default-mode networks following Floatation-REST. Hum Brain Mapp. 2021 Jul;42(10):3216-3227. doi: 10.1002/hbm.25429. Epub 2021 Apr 9.
- Individual participant dataSharing planned: No
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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.
Justin Feinstein, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floating in people with Anxiety, run by Laureate Institute for Brain Research, Inc. 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 2 inclusion and 9 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 22 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI) (time frame: fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452203, which also lists 1 linked publication.
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 22 Sep 2020.