Phase 2 Sleep Disorders Trial, Recruiting NCT05565833 Sponsor: University of Virginia Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT05565833
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:

  • People who are willing to sign and date a consent form agreeing to take part
  • People who are willing to follow all study procedures and are available for the full duration of the study
  • People who are male or female, aged 65 years or older
  • People who can speak and read English and currently live in the United States
  • People who have access to an internet-connected device (such as a computer, tablet, or smartphone) and are willing to receive study-related emails
  • People who have trouble falling asleep and/or staying asleep at night
  • People whose sleep problems (or related daytime tiredness) have been causing significant distress or affecting their social, work, or daily life for the past three months
  • People who show some level of cognitive (thinking or memory) difficulty based on a study assessment
  • People who have been on a stable medication routine, unless any of those medications are known to cause sleep problems

Who may not be able to join:

  • People who are currently receiving psychological treatment for insomnia
  • People who have started any psychological or psychiatric treatment within the past three months
  • People who have a current diagnosis of Huntington's or Parkinson's disease
  • People who are currently being treated for an overactive thyroid (hyperthyroidism)
  • People who are currently undergoing chemotherapy
  • People who have asthma or breathing concerns that may be affected by night-time treatment
  • People whose chronic pain is being managed with opioid medications
  • People who have not yet recovered from a brain tumour, brain injury, or brain infection
  • People who have epilepsy that has not been under stable treatment for at least three months
  • People who have an irregular or inconsistent sleep schedule
  • People who use stimulating medications after 5pm, or who have been taking such medications for less than three months
  • People who have a psychotic disorder or bipolar disorder
  • People who are assessed as being at moderate to high risk of suicide
  • People who have had issues with alcohol or drug misuse within the past year
  • People who have other untreated sleep disorders, such as obstructive sleep apnea
  • People whose study screening indicates severe depression

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 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: Meghan K Mattos, PhD, RN, CNL, University of Virginia

Phone: 434-243-3936

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
27 February 2023
Est. completion
1 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Insomnia Severity Index

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