NCT07578675

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Dec 2028

Study Start

First participant enrolled

October 11, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2.5 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Patients will be assessed within 48 hours of admission.

Secondary Outcomes (5)

  • Anxiety symptoms

    Patients will be assessed within 48 hours of admission.

  • Depression symptoms

    Patients will be assessed within 48 hours of admission.

  • Sleep quality

    Patients will be assessed within 48 hours of admission.

  • Physical fatigue

    Patients will be assessed within 48 hours of admission.

  • Appetite condition

    Patients will be assessed within 48 hours of admission.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with anemia who were hospitalized for the first time during the period from 2026 to 2028.

You may qualify if:

  • 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

You may not qualify if:

  • History of psychiatric illness
  • History of severe brain disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Anemia, AplasticMyelodysplastic SyndromesAnemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow DiseasesAnemia, HemolyticAutoimmune DiseasesImmune System Diseases

Central Study Contacts

ZheXiang Kuang, MSN

CONTACT

Xiao Yu, Undergraduate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

October 11, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations