Clinical trial NCT06633978: Studying the Effects of Digital Interventions on Cognition, Wellbeing, Stress, and Sleep in Older Adults
Official title: A Pilot Study of the Impact of Personalized Digital Meditation on Improving Sleep and Reducing Stress in MCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MCI
Aging
Keywords: meditation
sleep
stress
attention
cognition
memory
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mean change on the Continuous Performance Task (CPT) over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change in sleep quality
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change in measures of stress reactivity over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Secondary outcomes:
measure: Mean change in Telomere length (quantified in peripheral blood cells) over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change on a distracted attention task over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change in Frontal Theta Power over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change in resting state networks over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Other outcomes:
measure: Mean change on the Adaptive Cognitive Evaluation (ACE) over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean change in continuous recordings of sleep metrics.
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: mean change in Change in Mnemonic Discrimination over time
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: mean change in Task-based Cortical Functional Connectivity
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Everyday Cognition Scale (ECog)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on SF-36 (overall health)
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Perceived Stress Scale
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Pittsburgh Sleep Quality Index
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Epworth Sleepiness Scale
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Profile of Mood States
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Berlin Questionnaire
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
measure: Mean Change on Insomnia Severity Index
timeFrame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: David Ziegler, PhD
role: PRINCIPAL_INVESTIGATOR
References: