MCIMediDreamNCT06633978
Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults
A study testing MediTrain, wrist worn multi-sensor watches and Sleep monitor in people with MCI and Aging, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- What is being tested?
- MediTrain, wrist worn multi-sensor watches and Sleep monitor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI
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.
- Being tested
- MediTrain, wrist worn multi-sensor watches, Sleep monitor
- Keywords
- meditation, sleep, stress, attention, cognition, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediTrainDevice
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 watchesDevice
Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
Sleep monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MediTrain | Experimental | Not described Receives: Device: MediTrain; Device: wrist worn multi-sensor watches; Device: Sleep monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change on the Continuous Performance Task (CPT) over time
Measured: 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]
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start10 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- David A Ziegler, PhD, Principal investigator, University of California, San FranciscoChristine Walsh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633978
- Sponsor's protocol ID
- AG083503
- Other IDs
- R61AG083503
- Acronym
- MediDream
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI
- ClinicalTrials.gov ID
- NCT06633978
- Acronym / sponsor ID
- MediDream / AG083503
- Keywords
- meditation, sleep, stress, attention, cognition, memory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MediTrain | Experimental | Device: MediTrain, Device: wrist worn multi-sensor watches, Device: Sleep monitor |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MediTrainParticipants 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. | Device | MediTrain |
| wrist worn multi-sensor watchesStress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches. | Device | MediTrain |
| Sleep monitorSleep 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. | Device | MediTrain |
Primary outcome
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 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]
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
Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Ziegler, PhD principal investigator
University of California, San Francisco
Christine Walsh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MediTrain, wrist worn multi-sensor watches and Sleep monitor in people with MCI and Aging, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.