Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477289
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-20
Brief Title:
Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CirculRing with the WatchPAT in children ages 12-18 diagnosed with sickle cell disease
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 CirculRing with the WatchPAT in children ages 12-18 diagnosed with sickle cell disease
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None