A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- SCD
Study Overview
Brief Summary
This study is a 4-week group controlled trial to explore whether graphene far-infrared intervention can improve the cognitive status of older adults presenting with symptoms of Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), or Alzheimer's Disease (AD), and is dedicated to enhancing the cognitive status of older adults and improving their mental health. Participants were older adults who presented with cognitive problems. Participants were divided into SCD and MCI/AD groups based on their cognitive level, and each group was further divided into a graphene far-infrared intervention group and a placebo control group. We also measured the depression and anxiety levels of the older adults and incidentally observed whether the graphene far-infrared intervention could have a positive impact on their mental health outcomes, which was not the focus of our study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 55 years and above (age limit may be relaxed to not less than 45 years if there is a special desire to participate in the intervention)
- •No barriers to daily communication
- •Individuals participating voluntarily
Exclusion Criteria
- •Good cognitive functioning (SCD score of 0)
- •Subjective desire to withdraw
- •Individuals who reported discomfort opting out during the experimental procedure
Arms & Interventions
Graphene far infrared intervention group
The intervention group used the Graphene Far Infrared Intervention (GFII), in which a caregiver who had undergone standardized training wore a graphene cap that could heat up to 40°C on the elderly. The cap was worn by the elderly for a fixed period of time each day and removed after approximately 40 minutes. During the time of wearing the cap, the elderly can perform any activity (e.g., reading the newspaper, watching TV) within the length of the power cord in a sitting, lying, standing position, etc.
Intervention: a custom-made graphene therapy cap (Device)
Wear a normal heatable cap group
The placebo control group used ordinary hats that could be heated to about 40°C and were worn to the head of the elderly by caregivers who had undergone standardized training. The elderly wore the heat generating cap for a fixed period of time each day and removed it after about 40 minutes. During the period of wearing the cap, the elderly can sit, lie down, stand in the position of the length of the power cord, and carry out any activities (e.g., reading newspaper, watching TV)
Intervention: A regular cap that generates heat (Device)
Outcomes
Primary Outcomes
SCD
Time Frame: Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea
Depression was assessed by the Self-Rating Scale for Subjective Cognitive Decrease (SCD). The scale consists of 10 items that are scored from 1 (no change) to 3 (significant increase) based on the patient's self-reported subjective cognitive decompensation. A higher total score indicates more severe subjective cognitive decompensation.
MCI/AD
Time Frame: Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea
Cognitive function was assessed with the short form of the Montreal Cognitive Assessment (s-MoCA). The items are used to examine function in 6 cognitive domains (i.e., visuospatial/executive function, attention, language, abstraction, delayed memory, and orientation). If the number of years of education is less than or equal to 12, the total score is increased by 1 point. The total score ranges from 0 to 18: scores less than or equal to 11 indicate probable mild cognitive impairment (MCI), and scores less than or equal to 4 indicate probable Alzheimer's disease (AD).
Secondary Outcomes
- depression(Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea)
- Anxiety(Pre-intervention, 2 weeks after the start of the intervention, 4 weeks after the start of the intervention (at which point the intervention ended), 2 weeks after the end of the intervention, and 4 weeks after the end of the intervention (a total of 5 mea)