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Recruiting NCT06633978

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

No phase Interventional MCI Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MediTrain, wrist worn multi-sensor watches, Sleep monitor.
Who it may be relevant to
Registry conditions: MCI, Aging. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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 creati
  • Device 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.
  • Device 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.

Primary outcome measures

  • Mean change on the Continuous Performance Task (CPT) over time [Time frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
  • Mean change in sleep quality [Time frame: 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 [Time frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
Secondary outcome measures (4)
  • Mean change in Telomere length (quantified in peripheral blood cells) over time [Time frame: 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 [Time frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
  • Mean change in Frontal Theta Power over time [Time frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
  • Mean change in resting state networks over time [Time frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]

Eligibility criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06633978 · AG083503 · R61AG083503

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗