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L'essai clinique NCT06633978 (MediDream) pour MCI, Vieillissement est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults (MediDream)

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06633978 (MediDream) est un essai interventionnel pour MCI, Vieillissement. Son statut actuel est : en recrutement. L'étude a débuté le 10 septembre 2024 et vise à recruter 90 participants. Dirigé par l'Université de Californie à San Francisco, l'essai devrait être terminé d'ici le 1 février 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 octobre 2024.
Résumé succinct
The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.
Titre officiel

A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI

Conditions
MCIVieillissement
Autres identifiants de l'essai
Numéro NCT
NCT06633978
Date de début (réel)
2024-09-10
Dernière mise à jour publiée
2024-10-09
Date de fin (estimée)
2026-02
Inscription (estimée)
90
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
meditation
sleep
stress
attention
cognition
memory
Objectif principal
Prévention
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalMediTrain
Meditrain
Participants will engage with a digital meditation app for 30m/day for 6wks. MediTrain is a tablet-based, meditation-inspired, cognitive training game aimed at improving self-regulation of internal attention and distractions. It was developed in collaboration with meditation thought-leader Jack Kornfield, and Zynga, a world-class video game company. It was created to make benefits of concentrative meditation more easily accessible to anyone, including complete novices. This is achieved by creating a game that yields quantifiable and attainable goals, provides feedback, and includes an adaptive algorithm to gradually increase difficulty as users improve.
Wrist Worn Multi-sensor Watches
Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
Sleep Monitor
Sleep Profiler devices are FDA-cleared reduced-montage EEG recording devices that will be used in accordance with its FDA clearance. They are completely non-invasive and are designed to be comfortable enough to wear all night without interfering with normal sleep. These devices enable quality sleep recordings in the comfort of people's homes, rather than required an overnight stay at a sleep lab at UCSF.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Mean change on the Continuous Performance Task (CPT) over time
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in sleep quality
Mean change in sleep quality (i.e., total sleep time / time in bed, therefore this measure incorporates latency to sleep onset, total sleep time, wake after sleep onset and early morning waking, with higher numbers associated with better sleep) over time \[Time Frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants\]
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in measures of stress reactivity over time
Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Mean change in Telomere length (quantified in peripheral blood cells) over time
200 mL of blood will be collected from each participant before and after the intervention. Blood will be centrifuged for whole blood cell acquisition and stored at -80 °C for subsequent batch testing. Telomere length (T/S ratio) will be quantified in peripheral blood mononuclear cells.
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change on a distracted attention task over time
Mean performance on a distracted attention task will be compared pre and post intervention. Divided attention performance will be assessed using the Filter Task that places simultaneous demands on perceptual discrimination abilities and distraction filtering.
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in Frontal Theta Power over time
Based on previous studies of meditation training and our preliminary data, we predict that MediTrain will lead to significantly enhanced midline frontal theta power during the TOVA in MCI as compared to OA. Beyond most prior studies, by collecting structural MRI data, we will be able to source-localize any observed changes in midline frontal theta.
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Mean change in resting state networks over time
We also expect MediTrain will augment intrinsic Default Mode Network (DMN) connectivity, both functionally (measured with resting fMRI111,112) and structurally (measured with DTI-based connectomes). This is hypothesized based on the known association between the DMN,
baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Critères d'éligibilité

comfortably ambulatory healthy physical condition normal or corrected to normal visual auditory acuity fluency in spoken English Between 60-85 years old No neurological or psychiatric disorders No substance abuse Not taking anti-depressants Not taking anti-anxiety medication No history of seizures No color blindness No glaucoma No macular degeneration No amblyopia (lazy eye) No strabismus (cross eyed) Aneurysm clip(s) No Cardiac pacemaker No Implanted cardioverter defibrillator (ICD) No Electronic implant or device No Magnetically-activated implant or device No Neurostimulation system No Spinal cord stimulator No Internal electrodes or wires No Bone growth/bone fusion stimulator No Cochlear, otologic, or other ear implant No Insulin or other infusion pump No Implanted drug infusion device No type of prosthesis (eye, penile, etc.) No Heart valve prosthesis No Eyelid spring or wire No Artificial or prosthetic limb No Metallic stent, filter, or coil No Shunt (spinal or intraventricular) No Vascular access port and/or catheter No Radiation seeds or implants No Swan-Ganz or thermodilution catheter No Medication patch (Nicotine, Nitroglycerine) No metallic fragment or metallic foreign body in/on the body that can not be removed No Wire mesh implant No Tissue expander (e.g., breast) No Surgical staples, clips, or metallic sutures No Joint replacement (hip, knee, etc.) No Bone/joint pin, screw, nail, wire, plate, etc. No IUD, diaphragm, or pessary No Dentures or partial plates that can not be removed No Tattoo or permanent makeup No Body piercing jewelry No Claustrophobia
University of California, San Francisco logoUniversité de Californie à San Francisco711 essais cliniques actifs à explorer
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
Contact central de l'essai
Contact: David Ziegler, PhD, 415-476-2164, [email protected]
1 Centres de l'essai dans 1 pays

California

University of California, San Francisco, San Francisco, California, 94158, United States
David Ziegler, Contact, 415-476-2164, [email protected]
En recrutement