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

NCT ID: NCT06843824

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-05-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

a custom-made graphene therapy cap

Intervention Type: DEVICE

The GFII involved the use of a custom-made graphene therapy cap. The cap consisted of 3 parts: the main body of the cap, the thermostat and the power adapter. One end of the thermostat was connected to the main body of the cap, and the other end was connected to the power adapter; the adapter was plugged into a 220 V household power outlet. This turned on the cap, and the temperature could be adjusted. The light energy conversion rate of the graphene coating material used in the cap reached 90%, generating a temperature of 40 °C. Five caregivers were responsible for providing care for the elderly individuals. We will provided standardized training on the GFII to their caregivers. Each caregiver was responsible for assisting with the intervention of the elderly individuals that they usually cared for.

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)

Group Type: PLACEBO_COMPARATOR

A regular cap that generates heat

Intervention Type: DEVICE

The rest of the procedure is the same as the GFII group, but the cap used is a regular cap that can heat up to 40°C.

Interventions

a custom-made graphene therapy cap

The GFII involved the use of a custom-made graphene therapy cap. The cap consisted of 3 parts: the main body of the cap, the thermostat and the power adapter. One end of the thermostat was connected to the main body of the cap, and the other end was connected to the power adapter; the adapter was plugged into a 220 V household power outlet. This turned on the cap, and the temperature could be adjusted. The light energy conversion rate of the graphene coating material used in the cap reached 90%, generating a temperature of 40 °C. Five caregivers were responsible for providing care for the elderly individuals. We will provided standardized training on the GFII to their caregivers. Each caregiver was responsible for assisting with the intervention of the elderly individuals that they usually cared for.

Intervention Type: DEVICE

A regular cap that generates heat

The rest of the procedure is the same as the GFII group, but the cap used is a regular cap that can heat up to 40°C.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Psychology, Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Psychology, Chinese Academy of Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2023YFC3605304

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023YFC3605304-1

Identifier Type: -

Identifier Source: org_study_id