Subjective Cognitive Decrease (SCD)NCT06843824
A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults
A study testing Graphene-Based Far-Infrared Intervention in people with Subjective Cognitive Decrease (SCD) and Age-Related Cognitive Decline, run by Institute of Psychology, Chinese Academy of Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Subjective Cognitive Decrease (SCD), Age-Related Cognitive Decline
- What is being tested?
- Graphene-Based Far-Infrared Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 11 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years or older
- Residing in one of the participating long-term care facilities
- Able to communicate in daily life
- Willing to participate in the assigned study procedures and repeated assessments
Who cannot join
- Reporting no subjective cognitive decline on any item of the subjective cognitive decline questionnaire
- Having a medical condition that precluded localized head heating
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Psychology, Chinese Academy of Sciences
Beijing, Beijing Municipality, 100101
About this study
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.
- Being tested
- Graphene-Based Far-Infrared Intervention, Thermal-Effects Control
- Keywords
- Graphene Far Infrared Intervention (GFII), Older Adults, Subjective Cognitive Decrease (SCD), Far-Infrared Radiation, Long-Term Care, Cognitive Aging, Mini-Montreal Cognitive Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphene-Based Far-Infrared InterventionDevice
Also called GFII
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.
Thermal-Effects ControlDevice
Also called TEC
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.
| Study group | Role | What they receive |
|---|---|---|
| Graphene far infrared intervention group | Experimental | Participants received a graphene-based far-infrared intervention (GFII) using a wearable cap set to a nominal temperature of 40°C. Trained caregivers assisted participants with one 40-minute session daily for 4 weeks of active intervention. Participants could sit, lie down, or undertake routine activities during each session. Receives: Device: Graphene-Based Far-Infrared Intervention |
| Thermal-Effects Control Group | Active comparator | Participants received conventional electrical heating using a commercially available heated cap set to the same nominal temperature of 40°C. The intervention followed the same schedule, 40-minute session duration, and caregiver-assistance procedures as the GFII condition. Receives: Device: Thermal-Effects Control |
| Blank Control Group | No intervention | Participants received no cap-based intervention and continued their usual daily routines during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive Decline (SCD) Score
Subjective cognitive decline was assessed using a 10-item multidomain, example-assisted questionnaire. Participants rated perceived cognitive change relative to 1-2 years earlier on a three-point scale ranging from 1 (no decline) to 3 (obvious decline). Total scores range from 10 to 30, with higher scores indicating greater subjective cognitive decline.
Measured: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Mini-Montreal Cognitive Assessment (Mini-MoCA) Score
Objective cognitive performance was assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), which evaluates visuospatial and executive function, attention, language, abstraction, delayed recall, and orientation. Raw scores range from 0 to 17. Following the scoring instructions, one point was added for participants with fewer than 12 years of education, yielding an education-adjusted score range of 0 to 18. Higher scores indicate better cognitive performance. Scores were analyzed continuously and were not used for clinical diagnosis.
Measured: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Secondary outcomes (2)
Patient Health Questionnaire-9 (PHQ-9) Score
Depressive symptoms were assessed using the nine-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 (not at all) to 3 (nearly every day) based on the frequency of depressive symptoms during the preceding 2 weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores of 10 or higher indicate clinically relevant depressive symptoms.
Measured: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptoms were assessed using the Chinese version of the seven-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 (not at all) to 3 (nearly every day) based on the frequency of anxiety symptoms during the preceding 2 weeks. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Scores of 10 or higher indicate clinically relevant anxiety symptoms.
Measured: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completion11 May 2025
- Study completion11 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decrease (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychology, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843824
- Sponsor's protocol ID
- 2023YFC3605304-1
- Other IDs
- 2023YFC3605304
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level clinical outcome data underlying the findings reported in the publication will be available from the corresponding author upon reasonable request. Access to biomarker data will be considered separately, subject to ethical approval, data-use agreements, and applicable privacy requirements. Potentially identifying information will be withheld or minimized to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults
- ClinicalTrials.gov ID
- NCT06843824
- Acronym / sponsor ID
- 2023YFC3605304-1
- Keywords
- Graphene Far Infrared Intervention (GFII), Older Adults, Subjective Cognitive Decrease (SCD), Far-Infrared Radiation, Long-Term Care, Cognitive Aging, Mini-Montreal Cognitive Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Institute of Psychology, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 11 May 2025 (actual)
- Study completion
- 11 May 2025 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Graphene far infrared intervention group | Experimental | Device: Graphene-Based Far-Infrared InterventionParticipants received a graphene-based far-infrared intervention (GFII) using a wearable cap set to a nominal temperature of 40°C. Trained caregivers assisted participants with one 40-minute session daily for 4 weeks of active intervention. Participants could sit, lie down, or undertake routine activities during each session. |
| Thermal-Effects Control Group | Active comparator | Device: Thermal-Effects ControlParticipants received conventional electrical heating using a commercially available heated cap set to the same nominal temperature of 40°C. The intervention followed the same schedule, 40-minute session duration, and caregiver-assistance procedures as the GFII condition. |
| Blank Control Group | No intervention | –Participants received no cap-based intervention and continued their usual daily routines during the study period. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 55 years or older
- Residing in one of the participating long-term care facilities
- Able to communicate in daily life
- Willing to participate in the assigned study procedures and repeated assessments
Key exclusion criteria (2 listed)
- Reporting no subjective cognitive decline on any item of the subjective cognitive decline questionnaire
- Having a medical condition that precluded localized head heating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graphene-Based Far-Infrared InterventionAlso: GFIIThe 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 | Graphene far infrared intervention group |
| Thermal-Effects ControlAlso: TECThe 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. | Device | Thermal-Effects Control Group |
Primary outcome
Subjective Cognitive Decline (SCD) Score
Time frame: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Subjective cognitive decline was assessed using a 10-item multidomain, example-assisted questionnaire. Participants rated perceived cognitive change relative to 1-2 years earlier on a three-point scale ranging from 1 (no decline) to 3 (obvious decline). Total scores range from 10 to 30, with higher scores indicating greater subjective cognitive decline.
Mini-Montreal Cognitive Assessment (Mini-MoCA) Score
Time frame: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Objective cognitive performance was assessed using the Mini-Montreal Cognitive Assessment (Mini-MoCA), which evaluates visuospatial and executive function, attention, language, abstraction, delayed recall, and orientation. Raw scores range from 0 to 17. Following the scoring instructions, one point was added for participants with fewer than 12 years of education, yielding an education-adjusted score range of 0 to 18. Higher scores indicate better cognitive performance. Scores were analyzed continuously and were not used for clinical diagnosis.
2 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level clinical outcome data underlying the findings reported in the publication will be available from the corresponding author upon reasonable request. Access to biomarker data will be considered separately, subject to ethical approval, data-use agreements, and applicable privacy requirements. Potentially identifying information will be withheld or minimized to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graphene-Based Far-Infrared Intervention in people with Subjective Cognitive Decrease (SCD) and Age-Related Cognitive Decline, run by Institute of Psychology, Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive Decline (SCD) Score (time frame: Baseline (T1), after approximately 2 weeks of active intervention (T2), after completion of 4 weeks of active intervention (T3), and approximately 4 weeks after T3 (T4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.