Phase 3 Sleep Disorders Trial, Recruiting NCT06721819 Sponsor: Beth Israel Deaconess Medical Center Condition: Sleep Disorders
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Phase 3 Sleep Disorders Trial, Recruiting

NCT06721819
Recruiting Phase 3

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 scheduled to have heart surgery (bypass surgery with or without valve work, or valve surgery alone) that requires opening the breastbone and using a heart-lung bypass machine, and your surgery is planned at least 10 days from now.
  • You are 60 years of age or older.
  • You are willing to use a tablet and wearable devices provided by the study, and able to commit at least 1 hour per day before your surgery to complete the study activities (which may include a type of talk therapy, thinking exercises, and physical exercise) if you are placed in the active treatment group.

Who may not be able to join:

  • Your heart's pumping strength is very low (below 30%) based on pre-surgery testing.
  • Your surgery is scheduled as an emergency.
  • You are having surgery on the main large blood vessel from the heart (the aorta) only.
  • You have significant liver problems (confirm with trial site).
  • You have a known allergy or bad reaction to the study medications.
  • You have had a serious alcohol use problem in the past year, or have ever experienced severe alcohol withdrawal symptoms.
  • You are showing signs of confusion or disorientation at the start of the study.
  • You are not able to communicate in English.
  • Your doctor has said you should not participate.
  • You regularly use strong pain medications (opioids) at a significant daily dose for more than one month in the past year (confirm with trial site for exact amounts).
  • You have significant vision problems that would interfere with participation.
  • You are currently incarcerated.
  • You have severe sleep apnea (stopping breathing frequently during sleep) or very high daytime sleepiness scores (confirm with trial site for exact measurements).
  • You are already taking part in another unapproved treatment trial at the same time.
  • You have severe memory or thinking difficulties, or you take medications for cognitive decline.
  • You have received a specific talking therapy for insomnia (called CBT-I) within the last 6 months.

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
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 7814750572

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 3
Registry
ClinicalTrials.gov
Start date
6 June 2025
Est. completion
30 June 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Delirium Incidence

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