Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

NCT06477289 | Recruiting DMC

• 1 other identifier: PATSCANS
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  A linear regression model will be used to assess the relationship between SpO2 and neurocognitive functioning after adjusting for age, genotype, and social vulnerability.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

Secondary Outcomes (5)

• Assess differences in white matter integrity among children (ages 12-18) diagnosed with sickle cell disease with and without sleep disordered breathing.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• Assess differences in silent cerebral infarcts among children (ages 12-18) diagnosed with sickle cell disease with and without sleep disordered breathing.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• Assess differences in neuroinflammation, among children (ages 12-18) diagnosed with sickle cell disease with and without sleep disordered breathing.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• Assess differences in functional connectivity among children (ages 12-18) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• 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.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

Other Outcomes (3)

• 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

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• Assess the feasibility of an ultraportable ring oximeter (BodimetricsCircul+ Ring) in children (ages 12-18) diagnosed with sickle cell disease.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

• Assess the concordance between the Circul+Ring with the WatchPAT in children (ages 12-18) diagnosed with sickle cell disease.

  Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit participants ages 12-18 diagnosed with sickle disease of any genotype.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew Heitzer, Phd

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Heitzer, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Stephanie Guthrie, RN, BSN

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)