- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02452203
Examining the Effects of Reduced Environmental Stimulation on the Brain
18 septembre 2020 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
56
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74136
- Laureate Institute for Brain Research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 55 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Justin Feinstein, PhD, Laureate Institute for Brain Research
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2015
Achèvement primaire (Réel)
1 décembre 2019
Achèvement de l'étude (Réel)
31 décembre 2019
Dates d'inscription aux études
Première soumission
18 mai 2015
Première soumission répondant aux critères de contrôle qualité
21 mai 2015
Première publication (Estimation)
22 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 septembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 septembre 2020
Dernière vérification
1 septembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- float-fMRI-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .