NCT06477289 Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease
| NCT ID | NCT06477289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Sickle Cell Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 65 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 65 participants in total. It began in 2024-09-16 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine sleep disordered breathing and sleep quality in participants (ages 12-18) 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 children (ages 12-18) 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 children (ages 12-18) 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 children (ages 12-18) 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 children (ages 12-18) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability. Assess the feasibility of an ultraportable ring oximeter (BodimetricsCircul+ Ring) in children (ages 12-18) diagnosed with sickle cell disease. Assess the concordance between the Circul+Ring with the WatchPAT in children (ages 12-18) diagnosed with sickle cell disease.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with sickle cell disease of any genotype * Participant in the Sickle Cell Clinical Research and Intervention Program * Between 12-18 years of age at the time of enrollment * English is the primary language * Access to a smartphone or tablet for use with the Circul+ Ring 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.
Contact & Investigator
Andrew Heitzer, Phd
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT06477289 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06477289 currently recruiting?
Yes, NCT06477289 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT06477289 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT06477289 clinical trial?
NCT06477289 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Andrew Heitzer, Phd at St. Jude Children's Research Hospital. The trial plans to enroll 65 participants.
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