RECRUITING

Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Quick Facts

Study Start:2024-09-16
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with sickle cell disease of any genotype
  2. * Participant in the Sickle Cell Clinical Research and Intervention Program
  3. * Between 12-18 years of age at the time of enrollment
  4. * English is the primary language
  5. * Access to a smartphone or tablet for use with the Circul+ Ring
  1. * History of an intellectual disability
  2. * History of a traumatic brain injury or seizure disorder
  3. * History of a stroke
  4. * Undergoing potential curative treatment for SCD (stem cell transplant or gene therapy)
  5. * Currently prescribed an intervention for a sleep disorder
  6. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Contacts and Locations

Study Contact

Andrew Heitzer, PhD
CONTACT
8662785833
referralinfo@stjude.org
Stephanie Guthrie, RN, BSN
CONTACT
8662785833
referralinfo@stjude.org

Principal Investigator

Andrew Heitzer, Phd
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Andrew Heitzer, Phd, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Sickle Cell Disease