NCT05604547Completed
Exploring Near Infrared Spectroscopy (NIRS) Technologies for Assessment of Muscle Physiology, Tissue Oxygenation, and Blood Flow in Patients With Sickle Cell Disease (SCD)
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
Sickle cell disease (SCD) is an inherited disorder of the blood. SCD can injure the smallest blood vessels, which can cause pain and damage organs all over the body. Some treatments are available, but researchers need better ways to monitor the effects of these treatments. An imaging technique called near infrared spectroscopy (NIRS) may be helpful. Objective: To test NIRS as a tool for measuring oxygen levels, blood flow, and the makeup of skin and muscle in patients with SCD. Eligibility: People aged 18 years and older with SCD. Healthy volunteers are also needed as a comparison for the changes in SCD patients. Design: Participants will be screened. They will have a physical exam, and 1 teaspoon of blood will be drawn. Participants will have NIRS testing on their second visit. Probes will be placed on their skin. A blood pressure cuff will be placed on their arm. The cuff will be filled with air for up to 5 minutes and then released. Participants may be asked to breathe at a certain rate or hold their breath during these measurements. At this visit, participants will also have an ultrasound exam to get images of their heart. They will be monitored while they walk for 6 minutes. They will have 1 tablespoon of blood drawn. Their height, weight, and vital signs will be measured. Participants may be asked to return for up to 4 additional visits for NIRS testing within 120 days, but this is optional. The visits must be at least 3 days apart. Each visit will last up to an hour....
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 49 (actual)
- First submitted
- 2 Nov 2022
- Start date
- 28 Nov 2022
- Primary completion date
- 24 Jan 2025
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Diseases
- Sickle cell disease
- NCT number
- NCT05604547
What you commit to
- Study type: Observational
- Participants enrolled: 49
- From 28 Nov 2022 to the primary completion date, 24 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of Oxbryta (voxelotor), Adakveo (crizanlizumab), and/or Endari (L-glutamine) within the 12 weeks prior to signing consent
- Presence of an arterial-venous shunt, recent axillary node dissection, or any deformity or surgical history that interferes with proper access for brachial cuff occlusion procedure of the extremities
- Presence of an arterial-venous shunt, recent axillary node dissection, or any deformity or surgical history that interferes with proper access for brachial cuff occlusion procedure of the extremities
Other illness
- Sickle Cell Disease
Other
- Pain crisis requiring parenteral treatment within 4 weeks of screening/enrollment
- Blood transfusion within 60 days or exchange transfusion within 90 days of screening/enrollment
- Women who are currently pregnant
- Mobility difficulties causing the inability to complete 6-minute walk test
- Ethnically matched controls
- Women who are currently pregnant
- Mobility difficulties causing the inability to complete 6-minute walk test
- Blood transfusion within 60 days or exchange transfusion within 90 days of screening/enrollment
Criteria the registry did not label
- INCLUSION CRITERIA:
- Sickle Cell Disease
- Individuals with confirmed sickle cell disease (HbSS and S beta 0 genotypes)
- 18 years of age and older
- Willingness and capacity to provide informed consent
- Individuals must be on stable does of Hydroxyurea for 90 days prior to baseline visit
- Ethnically matched controls
- Individuals with HbAA genotype
- 18 years of age and older
- Willingness and capacity to provide informed consent
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.