Sleep Disorders Trial, Recruiting NCT05336084 Sponsor: University of Pittsburgh Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05336084
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:

  • People who are between 13 and 18 years old
  • People who are currently attending a traditional in-person high school (note: school closures during the COVID-19 pandemic are considered an exception to this requirement)
  • People who are in good physical and mental health
  • People (and their parent or guardian, if applicable) who are willing and able to provide written agreement to participate

Who may not be able to join:

  • People outside the 13 to 18 age range
  • People who have used alcohol, cannabis, or illicit drugs more than once a week at any point in the past year
  • People who have serious medical or neurological conditions, including a history of seizures
  • People who have serious mental health conditions, such as bipolar disorder or schizophrenia
  • People who are taking antidepressants (though certain types called SSRIs or SNRIs may be acceptable) or medications known to affect sleep — some medications may be considered acceptable if the person is able to stop taking them before or during certain parts of the study (confirm with trial site)
  • People who have sleep conditions other than insomnia or Delayed Sleep Phase Disorder (a condition where a person's sleep schedule is shifted significantly later than usual)
  • People who cannot undergo an MRI scan, for example due to metal implants in the body or claustrophobia (fear of enclosed spaces)
  • People who have a parent or sibling with bipolar disorder
  • People who experience frequent headaches or migraines
  • People who are unable to swallow pills or capsules
  • People who are pregnant
  • People found to have a breathing-related sleep condition called Obstructive Sleep Apnea, based on results from a sleep breathing test showing an Apnea Hypopnea Index (AHI) score above 5 (confirm with trial site for how this is measured)
  • People who weigh less than 80 pounds or who have a Body Mass Index (BMI) above 35

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 19 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: Peter L. Franzen, PhD, University of Pittsburgh

Phone: (412) 443-3704

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
Registry
ClinicalTrials.gov
Start date
4 March 2022
Est. completion
31 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.; Change in slope of waking EEG theta power; Melatonin onset

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: 19 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