Phase 4 Sleep Disorders Trial, Recruiting NCT07280468 Sponsor: University of Arizona Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT07280468
Recruiting Phase 4

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 6 years of age or older
  • People who have a diagnosis of Down syndrome
  • People of any gender or ethnicity
  • Adults who do not have a legally authorised representative must have a caregiver or support person who can co-sign consent forms and help complete study questionnaires

Who may not be able to join:

  • People who are currently using PAP therapy (a breathing device worn during sleep) consistently — meaning more than 4 hours per night for at least 70% of nights over the past 30 days, based on device records or caregiver reports
  • People who are currently taking MAO inhibitor medications (a type of medication used for certain conditions including depression)
  • People who have difficulty emptying their bladder (urinary retention)
  • People who have a seizure disorder
  • People who have an underactive thyroid (hypothyroidism) that is untreated or not adequately managed
  • People who have a significant traumatic brain injury
  • People who have a heart condition present from birth (congenital heart disease) that requires at least yearly cardiology appointments, unless their cardiologist has cleared them to take part in the study
  • People who have a current diagnosis of depression that is not being treated
  • People who have a history of liver disease (not including a specific type of fatty liver condition known as metabolic dysfunction-associated steatotic liver disease)
  • Children only — people with a tonsil size rated at 3 or higher on a standard medical scale (this restriction does not apply to adults) (confirm with trial site)

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Daniel Combs, MD, University of Arizona

Phone: 520-403-6165

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
Phase 4
Sponsor
University of Arizona
Registry
ClinicalTrials.gov
Start date
14 March 2026
Est. completion
1 January 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

obstructive apnea-hypopnea index (oAHI)

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: 27 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