Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-25
SponsorSt. Jude Children's Research Hospital
About this trial
This study will examine sleep disordered breathing and sleep quality in participants (ages 12-25) 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 individuals (ages 12-25) 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 individuals (ages 12-25) 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 individuals (ages 12-25) 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 individuals (ages 12-25) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability.
Assess the feasibility of an optical imaging tool (Speckle Contrast Optical Spectroscopy - Open-Motion 3.0) to measure cerebral blood flow and blood volume in patients diagnosed with sickle cell disease (ages 12-25).
Assess the concordance between measurement of cerebral blood flow and volume using speckle contrast optical spectroscopy and arterial spin labeling brain MRI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with sickle cell disease of any genotype
Participant in the Sickle Cell Clinical Research and Intervention Program
Between 12-25 years of age at the time of enrollment
English is the primary language
Disqualifiers
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)
Trial population
The study will recruit participants ages 12-25 diagnosed with sickle disease of any genotype.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the relationship between nocturnal oxyhemoglobin saturation (SpO2) and neurocognitive functioning (working memory and verbal comprehension) in individuals (ages 12-25) 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.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.Secondary outcomes
1
Assess differences in white matter integrity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing.
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 individuals with and without sleep disordered breathing.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.2
Assess differences in silent cerebral infarcts among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing.
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 individuals with and without sleep disordered breathing.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.3
Assess differences in neuroinflammation, among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing.
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 individuals with and without sleep disordered breathing.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.4
Assess differences in functional connectivity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age.
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 individuals with and without sleep disordered breathing.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.Other outcomes
1
Explore the association among nocturnal SpO2 and neurocognitive function (attention, processing speed, verbal/visual memory, motor dexterity) in individuals aged 12-25 years with sickle cell disease adjusting for age, genotype, and social vulnerability.
A linear regression model will be used to assess the relationship between SpO2 and neurocognitive functioning after adjusting for age, genotype, and social vulnerability
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.2
Assess the feasibility of an ultraportable ring oximeter (BodimetricsCircul+ Ring) in individuals (ages 12-25) diagnosed with sickle cell disease.
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.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.3
Assess the concordance between the Circul+Ring with the WatchPAT in individuals (ages 12-25) diagnosed with sickle cell disease.
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.
Time frame
Baseline remote sleep assessment over 3 days followed by in-clinic assessment.Sponsors and contacts
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Source ClinicalTrials.gov