Aplastic AnemiaAN-CNANCT07578675
Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS
An observational study of Aplastic Anemia and Myelodysplastic Syndromes, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aplastic Anemia, Myelodysplastic Syndromes, Autoimmune Hemolytic Anemia
- How many people
- 323 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anemia who were hospitalized for the first time during the period from 2026 to 2028.
Who may be able to join
- Diagnosis of anemia
- First hospitalization
- Male or female, aged 18-65 years
- Willing and able to comply with the requirements for this study and written informed consent
Who cannot join
- History of psychiatric illness
- History of severe brain disease
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Regenerative Medicine Center
Tianjin, Tianjin Municipality
Xiao Yu, Undergraduate, 18722218448, yuxiao@ihcams.ac.cn
About this study
Official title: Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)
Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression.
Functional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.
- Conditions
- Aplastic Anemia, Myelodysplastic Syndromes, Autoimmune Hemolytic Anemia, Functional Near-Infrared Spectroscopy
- Medical subject headings
- Anemia, Aplastic, Myelodysplastic Syndromes, Anemia, Hemolytic, Autoimmune
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.
Measured: Patients will be assessed within 48 hours of admission.
Cognitive Function Assessment
Montreal Cognitive Assessment (MoCA) is used to assess cognitive function in patients, with higher total scores indicating better cognitive function. The total score range is 0 to 30.
Measured: Patients will be assessed within 48 hours of admission.
Secondary outcomes (5)
Anxiety symptoms
Hamilton anxiety scale(HAMA) is used to examine anxiety in AIHA patients, with higher total scores indicate more severe anxiety symptoms. The total score range is 0-56.
Measured: Patients will be assessed within 48 hours of admission.
Depression symptoms
Hamilton depression scale(HAMD) is used to examine depression in AIHA patients, with higher total scores indicate more severe depression symptoms. The total score range is 0-52.
Measured: Patients will be assessed within 48 hours of admission.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, with a higher global score indicating poorer sleep quality. The global score range is 0-21.
Measured: Patients will be assessed within 48 hours of admission.
Physical fatigue
It measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale. The total possible score is 0-52 points, with higher scores indicating less fatigue.
Measured: Patients will be assessed within 48 hours of admission.
Appetite condition
Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess appetite in patients, with higher total scores indicating better appetite. The total score range is 4 to 20.
Measured: Patients will be assessed within 48 hours of admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start11 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578675
- Sponsor's protocol ID
- QTJC2026037
- Acronym
- AN-CNA
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)
- ClinicalTrials.gov ID
- NCT07578675
- Acronym / sponsor ID
- AN-CNA / QTJC2026037
- Conditions
- Aplastic Anemia, Myelodysplastic Syndromes, Autoimmune Hemolytic Anemia, Functional Near-Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Tianjin University
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 May 2026 (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.
Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression.
Functional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anemia who were hospitalized for the first time during the period from 2026 to 2028.
Key inclusion criteria (4 listed)
- Diagnosis of anemia
- First hospitalization
- Male or female, aged 18-65 years
- Willing and able to comply with the requirements for this study and written informed consent
Key exclusion criteria (3 listed)
- History of psychiatric illness
- History of severe brain disease
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Time frame: Patients will be assessed within 48 hours of admission.
Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.
Cognitive Function Assessment
Time frame: Patients will be assessed within 48 hours of admission.
Montreal Cognitive Assessment (MoCA) is used to assess cognitive function in patients, with higher total scores indicating better cognitive function. The total score range is 0 to 30.
5 secondary outcomes
Anxiety symptoms
Time frame: Patients will be assessed within 48 hours of admission.
Depression symptoms
Time frame: Patients will be assessed within 48 hours of admission.
Sleep quality
Time frame: Patients will be assessed within 48 hours of admission.
Physical fatigue
Time frame: Patients will be assessed within 48 hours of admission.
Appetite condition
Time frame: Patients will be assessed within 48 hours of admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aplastic Anemia and Myelodysplastic Syndromes, run by Institute of Hematology & Blood Diseases Hospital, China 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 3 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: looking for participants now, as of the sponsor's last update on 18 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZheXiang Kuang, MSN (13920361752, kuangzhexiang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR) (time frame: Patients will be assessed within 48 hours of admission.). 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 18 Sep 2026.