Fact CheckerSign in

NCT06477289Recruiting

Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

This study will examine sleep disordered breathing and sleep quality in participants (ages 12-25) diagnosed with sickle cell disease of any genotype. We will utilize remote peripheral arterial tonometry (PAT) and questionnaires to evaluate difficulties with sleep. PAT assessments will occur remotely in the homes of participants. Neurocognitive, behavioral, and neuroimaging evaluations will occur on the same day as a routine clinic visit. Primary Objective: Evaluate the relationship between nocturnal oxyhemoglobin saturation (SpO2) and neurocognitive functioning (working memory and verbal comprehension) in individuals (ages 12-25) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability. Secondary Objective: Assess differences in white matter integrity, silent cerebral infarcts, neuroinflammation, and functional connectivity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age. Assess differences in self- and caregiver-reported mood and pain severity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age. Exploratory Objectives: Explore the relationship between nocturnal oxyhemoglobin saturation (SpO2) and neurocognitive functioning (attention, processing speed, verbal memory, visual memory, motor dexterity) in individuals (ages 12-25) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability. Assess the feasibility of an optical imaging tool (Speckle Contrast Optical Spectroscopy - Open-Motion 3.0) to measure cerebral blood flow and blood volume in patients diagnosed with sickle cell disease (ages 12-25). Assess the concordance between measurement of cerebral blood flow and volume using speckle contrast optical spectroscopy and arterial spin labeling brain MRI.

Status (registry)
Recruiting
Study type
Observational
Enrollment
65 (estimated)
First submitted
20 Jun 2024
Start date
16 Sept 2024
Primary completion date
Jun 2027
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT06477289

What you commit to

  • Study type: Observational
  • Planned participants: 65
  • From 16 Sept 2024 to the primary completion date, Jun 2027
  • 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

  • Undergoing potential curative treatment for SCD (stem cell transplant or gene therapy)

Other illness

  • History of an intellectual disability
  • History of a traumatic brain injury or seizure disorder
  • History of a stroke
  • Currently prescribed an intervention for a sleep disorder

Other

  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Who the study is looking for

  • Diagnosed with sickle cell disease of any genotype
  • Participant in the Sickle Cell Clinical Research and Intervention Program
  • Between 12-25 years of age at the time of enrollment
  • English is the primary language
  • Access to an electronic device with WiFi

Age in the registry: 12 years to 25 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.