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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Mean change on the Continuous Performance Task (CPT) over time [Срок оценки: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
• Mean change in sleep quality [Срок оценки: 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 [Срок оценки: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]

Вторичные конечные точки (4)

• Mean change in Telomere length (quantified in peripheral blood cells) over time [Срок оценки: 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 [Срок оценки: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
• Mean change in Frontal Theta Power over time [Срок оценки: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]
• Mean change in resting state networks over time [Срок оценки: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06633978 · AG083503 · R61AG083503

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗