Clinical trial Recruiting at 1 site Observational Ages 12 to 25

Examining sleep and brain function in children with sickle cell disease

Official title: Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease

Run by St. Jude Children's Research Hospital · NCT06477289 · Data updated 2026-11-12

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 typeObservational
Ages12 Years to 25 Years
SexAll
Enrollment65 (estimated)
SponsorSt. Jude Children's Research Hospital
Academic / other
Locations1 site (Memphis, Tennessee)
StatusRecruiting
StartedSeptember 16, 2024
Main results expectedJune 2027
Study endsJune 2028
Registry record updatedJune 29, 2026
Trial IDNCT06477289 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While there is ongoing research into sleep disorders in sickle cell disease, this specific approach utilizing remote monitoring and neurocognitive assessments is relatively novel.

Who can join: the full rules

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 12-25 years of age at the time of enrollment
* English is the primary language
* Access to an electronic device with WiFi

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

    This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

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  • Adapting and testing PEN-Plus in Zambian primary care

    Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

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  • Newborn Sickle Cell Screening in Mozambique

    We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

    Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

  • Optimizing Hydroxyurea in Children with Sickle Cell in Africa

    This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.

    Recruiting Phase 1/2 Children's Hospital Medical Center, Cincinnati · Kampala · NCT07708714

  • Hematopoietic stem cell editing to treat sickle cell disease

    This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.

    Recruiting Phase 1 Boston Children's Hospital · Boston, Massachusetts · NCT07708350

  • Virtual reality options to help with VOC pain in adults with SCD

    This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.

    Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT07674277

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.