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

NCT06633978 | Recruiting FDA Device

• 2 other identifiers: AG083503R61AG083503
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MCI; Aging

Keywords

meditation; sleep; stress; attention; cognition; memory

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Mean change in Telomere length (quantified in peripheral blood cells) over time

  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

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

• Mean change in Frontal Theta Power over time

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

• Mean change in resting state networks over time

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

Other Outcomes (12)

• Mean change on the Adaptive Cognitive Evaluation (ACE) over time

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

• Mean change in continuous recordings of sleep metrics.

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

• mean change in Change in Mnemonic Discrimination over time

  baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants

Study Arms (1)

MediTrain

EXPERIMENTAL

Device: MediTrain; Device: wrist worn multi-sensor watches; Device: Sleep monitor

Interventions

Sleep monitor DEVICE

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.

MediTrain

MediTrain DEVICE

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.

MediTrain

wrist worn multi-sensor watches DEVICE

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

MediTrain

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Study Officials

• David A Ziegler, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Christine Walsh, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Chen, PhD

CONTACT

415-476-2164; medidream@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)