Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Recruiting

• Conditions: Sickle Cell Disease

• Registration Number: NCT06477289
• Lead Sponsor: St. Jude Children's Research Hospital

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.
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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 eq...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-27
• Study Start: 2024-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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 function...
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.	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 ...
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.	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 ...
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.	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 ...
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.	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 ...

Trial Locations

Locations (1)

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