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COMPLETED
NCT06843824
NA

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

Sponsor: Institute of Psychology, Chinese Academy of Sciences

View on ClinicalTrials.gov

Summary

This study was a 4-week facility-level cluster-controlled trial examining whether a graphene-based far-infrared intervention could improve cognitive status among older adults living in long-term care facilities. Five facilities were assigned to one of three study conditions: a graphene-based far-infrared intervention (GFII), a thermal-effects control (TEC) delivered using an electrically heated cap at the same nominal temperature, or a blank control condition without intervention. Participants in the GFII and TEC groups received one 40-minute session daily for 4 weeks. Cognitive outcomes were assessed at baseline, after approximately 2 and 4 weeks of intervention, and at a 4-week post-intervention follow-up. Depressive and anxiety symptoms were also assessed as exploratory outcomes, although they were not the primary focus of the study. The study aimed to examine whether GFII could improve cognitive status beyond the effects of thermal stimulation alone or no intervention.

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-03-01

Completion Date

2025-05-11

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DEVICE

Graphene-Based Far-Infrared Intervention

The GFII was delivered using a custom wearable cap comprising a flexible cap body with graphene-coated elements, a temperature controller, and an external power adapter. The cap covered the frontal, temporal, and occipital scalp regions and emitted far-infrared radiation primarily within the 4-14 μm range. The device was operated at a nominal temperature of 40°C. Participants received one 40-minute session daily for 4 weeks of active intervention under the assistance and supervision of trained caregivers.

DEVICE

Thermal-Effects Control

The thermal-effects control was delivered using a commercially available electrically heated cap without graphene-based far-infrared-emitting elements. The cap was operated at the same nominal temperature of 40°C and followed the same intervention schedule, 40-minute session duration, and caregiver-assistance procedures as the GFII condition.

Locations (1)

Institute of Psychology, Chinese Academy of Sciences

Beijing, Beijing Municipality, China