Phase 4 Sleep Disorders Trial, Recruiting NCT05823844 Sponsor: Columbia University Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT05823844
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:

  • You are between 50 and 90 years old.
  • You are scheduled for a planned (non-emergency) surgery such as hip or knee replacement, hernia repair, kidney cancer surgery, urologic, gynecologic, or spine surgery, and you are expected to stay in the hospital for at least 24 hours afterward.
  • You have had trouble sleeping — such as difficulty falling asleep, waking up too early, or staying asleep — at least 3 nights per week for the past 3 months.

Who may not be able to join:

  • You are expected to be admitted to an intensive care unit (ICU) after your surgery.
  • You are having heart bypass surgery or other heart-related surgeries.
  • You are having surgery inside the skull or brain.
  • You are currently taking high doses of strong prescription pain medication (more than 60 mg of oxycodone or an equivalent amount of a similar medication) outside of a hospital setting.
  • You have a condition that disrupts your body's natural sleep-wake cycle (such as shift work sleep disorder) (confirm with trial site).
  • You score high on a standard questionnaire used to measure depression in older adults (confirm with trial site).
  • You have moderate to severe memory or thinking problems (dementia), based on a screening test (confirm with trial site).
  • You have severe sleep apnea, meaning your breathing stops and starts frequently during sleep.
  • You are currently taking certain medications that affect how the body processes other drugs — including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, grapefruit (as a medication interaction), phenobarbital, phenytoin, rifampicin, St. John's Wort, or steroid medications (confirm with trial site).
  • You are a child or are currently pregnant.

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 6 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: Paul S. Garcia, MD PhD, Columbia University

Phone: 212-304-7523

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
Registry
ClinicalTrials.gov
Start date
1 May 2023
Est. completion
1 May 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Total sleep time on day 0 (TST)

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: 6 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