- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02452203
Examining the Effects of Reduced Environmental Stimulation on the Brain
18 de septiembre de 2020 actualizado por: Justin Feinstein, Laureate Institute for Brain Research, Inc.
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
56
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Laureate Institute for Brain Research
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Floating
The participant will float supine in water with a high concentration of Epsom salt for 90 minutes.
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Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
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Comparador de placebos: Chair
The participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes.
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Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
Periodo de tiempo: fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks
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MRI scan to measure the blood flow changes in the brain
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fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Justin Feinstein, PhD, Laureate Institute for Brain Research
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2015
Finalización primaria (Actual)
1 de diciembre de 2019
Finalización del estudio (Actual)
31 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2015
Publicado por primera vez (Estimar)
22 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- float-fMRI-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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