Examining sleep and brain function in children with sickle cell disease
Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease
This study is trying to see how sleep quality affects brain function in children with sickle cell disease by using special devices at home and tests at the clinic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06477289 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between sleep quality and neurocognitive functioning in children aged 12-18 diagnosed with sickle cell disease. Participants will use remote peripheral arterial tonometry (PAT) devices at home to assess sleep disordered breathing and complete questionnaires about their sleep behaviors. Following this, they will attend a clinic visit for neurocognitive assessments and neuroimaging. The study aims to understand how nocturnal oxygen levels relate to cognitive abilities while controlling for various factors.
Who should consider this trial
Good fit: Ideal candidates are children aged 12-18 with any genotype of sickle cell disease who can participate in the Sickle Cell Clinical Research and Intervention Program.
Not a fit: Patients with a history of intellectual disabilities, traumatic brain injuries, or those currently receiving treatment for sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sleep-related issues in children with sickle cell disease, potentially enhancing their cognitive function and overall quality of life.
How similar studies have performed: While there is ongoing research into sleep disorders in sickle cell disease, this specific approach utilizing remote monitoring and neurocognitive assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Heitzer, Phd — St. Jude Children's Research Hospital
- Study coordinator: Andrew Heitzer, PhD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.