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Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 days
  • Procedures mentioned: Questionnaires, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will utilize remote peripheral arterial tonometry (PAT) and questionnaires to evaluate difficulties with sleep."
  • "Assess the concordance between measurement of cerebral blood flow and volume using speckle contrast optical spectroscopy and arterial spin labeling brain MRI."
  • "After receiving the questionnaires and equipment, a virtual session will be conducted with the participant to provide education on how to use the equipment and complete the included questionnaires."
  • "Participants will wear the WatchPAT overnight for three days and data will be captured remotely."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how sleep, breathing during sleep, and blood oxygen levels relate to memory and thinking in people ages 12–25 with any type of sickle cell disease. Participants will use a sleep test at home and answer questions about sleep. Tests of thinking and behavior, along with brain scans, will take place on the day of a regular clinic visit.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have any type of sickle cell disease.
  • Be in the Sickle Cell Clinical Research and Intervention Program.
  • Be 12–25 years old when joining the study.
  • Use English as your main language.
  • Have access to an electronic device with WiFi.

Who can't join

  • Have a history of intellectual disability, which affects learning and daily living skills.
  • Have a history of brain injury caused by trauma or a seizure disorder.
  • Have had a stroke.
  • Be receiving a stem cell transplant or gene therapy that may cure sickle cell disease.
  • Currently have a prescribed treatment for a sleep disorder.
  • You or your legal guardian or representative cannot or will not give written consent to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * History of an intellectual disability * History of a traumatic brain injury or seizure disorder * History of a stroke * Undergoing potential curative treatment for SCD (stem cell transplant or gene therapy) * Currently prescribed an intervention for a sleep disorder * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Study sites (1)

TN