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RECRUITINGOBSERVATIONAL

Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (1)

St. Jude Children's Research Hospital
Memphis, Tennessee, United States