Phase 2 Sleep Disorders Trial, Recruiting NCT05282550 Sponsor: Johns Hopkins University Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT05282550
Recruiting Phase 2

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 have been diagnosed with Mild Cognitive Impairment (MCI), meaning you have memory concerns reported by yourself and/or shown through testing
  • Your memory impairment has been rated as mild on a standard assessment called the Clinical Dementia Rating scale (score of 0.5, with memory score of 0.5 or higher)
  • You have sleep problems, shown by scoring above 5 on a standard sleep quality questionnaire called the Pittsburgh Sleep Quality Index
  • Your memory test scores are notably lower than what is typical for people your age and education level (confirm with trial site for specific tests used)
  • You have good enough vision and hearing to complete thinking and memory tests
  • You are in generally good health with no serious illness that would interfere with the study
  • You are able to have an MRI scan
  • You have a family member, friend, or caregiver who knows you well and can provide information about you

Who may not be able to join:

  • You are younger than 55 years old
  • You are too physically unwell or frail to take part in the study procedures
  • You have already been diagnosed with obstructive sleep apnea, or a sleep breathing test shows you have moderate-to-severe sleep apnea
  • You have been diagnosed with dementia
  • Your memory or thinking problems are better explained by another medical or neurological condition
  • You are currently experiencing delirium (sudden confusion)
  • You are allergic to the medication trazodone
  • You are currently taking sleep medications, including trazodone
  • You are currently misusing alcohol or drugs
  • You are currently experiencing a major depressive episode, a manic episode, or an acute psychotic episode
  • You have a serious or unstable medical condition that could make it hard to follow the study plan, or that could itself be causing your memory problems
  • You do not have a family member, friend, or caregiver who can provide information about you
  • You have a specific heart rhythm measurement (QTc interval) that is above a certain level — above 470 milliseconds for women or above 450 milliseconds for men (confirm with trial site)
  • You are not able to give your own informed consent to participate

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 26 July 2026
Phase 2: approximately ~30% 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

Principal Investigator: Barry Greenberg, PhD, Johns Hopkins University

Phone: 410-955-1696

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 2
Registry
ClinicalTrials.gov
Start date
2 February 2023
Est. completion
30 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in total sleep duration between the treatment arms; Change in Slow Wave Sleep (SWS) duration between the treatment arms; Change in SWS intensity between the treatment arms; Change in sleep onset latency between the treatment arms; Change in sleep fragmentation between the treatment arms; Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment arms; Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms

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: 26 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