RecruitingNot ApplicableNCT06633978

Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults

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


Sponsor

University of California, San Francisco

Enrollment

90 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Inclusion Criteria48

  • 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

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Interventions

DEVICEMediTrain

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.

DEVICEwrist worn multi-sensor watches

Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.

DEVICESleep 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.


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06633978


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