A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults

Institute of Psychology, Chinese Academy of Sciences

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment (MCI); Subjective Cognitive Decrease (SCD); Alzheimer's Disease(AD); Depression/Anxiety Symptoms

Treatments: Device: A regular cap that generates heat; Device: a custom-made graphene therapy cap

Study type: Interventional

Funder types: Other

Identifiers

NCT06843824

2023YFC3605304 (Other Grant/Funding Number)

2023YFC3605304-1

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Graphene far infrared intervention group

Experimental group

Description:

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.

Treatment:

Device: a custom-made graphene therapy cap

Wear a normal heatable cap group

Placebo Comparator group

Description:

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)

Treatment:

Device: A regular cap that generates heat