Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

April 23, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Interested participants will be consented in-person or virtually. Consented participants will be mailed the equipment (WatchPAT and Circul+ Ring) to conduct the remote assessment. Additional questionnaires will also be sent via mail or email for the participant to complete prior to collecting data on sleep behaviors. 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 and Circul+ Ring overnight for three days and data will be captured remotely. After wearing the devices for three consecutive nights, the participant will attend a research visit within approximately the next two weeks where they will complete performance based neurocognitive assessments, behavioral rating forms, and neuroimaging.

Study Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess differences in white matter integrity among children (ages 12-18) diagnosed with sickle cell disease with and without sleep disordered breathing.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
This study will measure resting-state BOLD signal in SCD patients after assessing nocturnal oxyhemoglobin saturation. The primary endpoint is the whole brain BOLD response and functional connectivity among brain regions within the default mode, fronto-parietal, executive control, salience, sensorimotor, and other resting state networks. Then we will compare differences in white matter integrity based on the structural connectivity connectome for the working memory network, silent cerebral infarcts, neuroinflammation, and functional connectivity among children 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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
This study will measure resting-state BOLD signal in SCD patients after assessing nocturnal oxyhemoglobin saturation. The primary endpoint is the whole brain BOLD response and functional connectivity among brain regions within the default mode, fronto-parietal, executive control, salience, sensorimotor, and other resting state networks. Then we will compare differences in white matter integrity based on the structural connectivity connectome for the working memory network, silent cerebral infarcts, neuroinflammation, and functional connectivity among children 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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
This study will measure resting-state BOLD signal in SCD patients after assessing nocturnal oxyhemoglobin saturation. The primary endpoint is the whole brain BOLD response and functional connectivity among brain regions within the default mode, fronto-parietal, executive control, salience, sensorimotor, and other resting state networks. Then we will compare differences in white matter integrity based on the structural connectivity connectome for the working memory network, silent cerebral infarcts, neuroinflammation, and functional connectivity among children 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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
This study will measure resting-state BOLD signal in SCD patients after assessing nocturnal oxyhemoglobin saturation. The primary endpoint is the whole brain BOLD response and functional connectivity among brain regions within the default mode, fronto-parietal, executive control, salience, sensorimotor, and other resting state networks. Then we will compare differences in white matter integrity based on the structural connectivity connectome for the working memory network, silent cerebral infarcts, neuroinflammation, and functional connectivity among children with and without sleep disordered breathing.
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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
The general linear regression model is then used to assess the relationship of functional connectivity and to assess the relationship of self- and caregiver-reported mood and pain severity with sleep disordered breathing with controlling for age in the model. As a secondary analysis, we will also associate continuous obstructive and central AHI with functional connectivity and self- and caregiver-reported mood and pain severity using linear regression model with adjusting for age.
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
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.
Assess the feasibility of an ultraportable ring oximeter (BodimetricsCircul+ Ring) in children (ages 12-18) diagnosed with sickle cell disease.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
Feasibility of the Circul+Ring equipment will be defined as more than 50% of participants wearing Circul+Ring for at least one night's sleep. There is no power calculation needed for this feasibility objective. However, 55 participants give 92% power to detect a 20% difference at an assumed 70% of participants who will wear the ring for at least one night's sleep, with a significance level of 0.05 based on a one-sided test. The number of hours worn for the WatchPAT and Circul+Ring will be compared using Wilcoxon rank sum test. Descriptive statistics will be used to summarize the two-question survey.
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.
Time Frame: Baseline remote sleep assessment over 3 days followed by in-clinic assessment.
To evaluate concordance, the nocturnal SpO2 obtained using the WatchPAT and a Circul+ Ring will be plotted against each other, and Pearson/Spearman correlations will be used to examine their relationship. The Bland-Altman method will be used to investigate the variability between the two measurements using the WatchPAT and Circul+ Ring. Lin's concordance correlation coefficient will be determined to demonstrate the level of agreement.
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Andrew Heitzer, PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATSCANS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe