Sleep Disorders Trial, Recruiting NCT06396520 Sponsor: Danish Research Centre for Magnetic Resonance Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06396520
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For babies identified as high-risk (detected shortly after birth):

  • Babies born before 32 weeks of pregnancy
  • Babies born weighing less than 1,500 grams (about 3.3 pounds)
  • Babies diagnosed with a moderate to severe brain injury, such as bleeding in the brain, damage to brain tissue, stroke, oxygen deprivation at birth, or another serious neurological condition
  • Babies with a history of certain complications (such as seizures, serious infections like meningitis, or severe low blood sugar) or early signs of neurological concerns (such as unusual muscle tone or brain structure differences)

For babies identified as high-risk during infancy:

  • Babies who are not able to sit on their own by 9 months of age
  • Babies showing differences in how they use one hand compared to the other, or differences in how they crawl
  • Babies who are not able to put their full weight through the soles of their feet
  • Babies with a history of complications or early signs of neurological concerns (as listed above)

For typically developing babies (comparison group):

  • Babies born at 37 weeks of pregnancy or later
  • Babies with no complications during birth
  • Babies with no known history of brain injury
  • Babies with no neurological conditions

For all groups:

  • Families must agree to allow relevant health information from the trial assessments to be shared with the child's doctors or primary care physician

Who may not be able to join:

  • Babies for whom MRI scans are not safe — for example, those with a pacemaker or other implanted electronic device
  • Families who do not speak or understand Danish
  • Families who do not wish to be told about unexpected findings discovered during the MRI or about results from the neurological, movement, or thinking assessments that fall outside the normal range

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Kathrine Skak Madsen, PhD, Senior Researcher

Phone: +4561145571

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Danish Research Centre for Magnetic Resonance
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
31 December 2027

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Diffusion-weighted magnetic resonance imaging; Brain volumetric measures; Cortical thickness; Brain connectivity measures; Indices of myelination; MR-spectroscopy measures; Surface area

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov