PTSD Trial, Recruiting NCT06419959 Sponsor: VA Office of Research and Development Condition: PTSD
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PTSD Trial, Recruiting

NCT06419959
Recruiting Not Applicable

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 have been diagnosed with PTSD according to the DSM-5 (the standard diagnostic guidelines used by mental health professionals)
  • People who report having repeated nightmares that disturb their sleep
  • People who are 22 years of age or older
  • People whose resting blood pressure is below 160/100 mmHg
  • People whose fasting blood sugar level is below 126 mg/dL
  • People with poor overall sleep quality, as measured by a standard sleep questionnaire (a score of 6 or higher on the Pittsburgh Sleep Quality Index)
  • People who, if they report feeling drowsy at times, do not drive while drowsy (this is assessed via a standard sleepiness questionnaire and is required for safety reasons)
  • People who have wireless internet and two power outlets available in the place where they sleep
  • People who are willing to not use any other apps that collect heart rate data on the phone or watch used with the NightWare device during the trial

Who may not be able to join:

  • People with an unstable medical condition, such as uncontrolled high blood pressure, active heart or blood vessel disease, or active cancer
  • People who currently have an active infection (though eligibility may be reconsidered once the infection has cleared — confirm with trial site)
  • People with a thyroid condition where thyroid hormone levels fall outside a specific range — though eligibility may be reconsidered after follow-up care from a primary care doctor (confirm with trial site)
  • People who currently use insulin or a type of diabetes medication called sulfonylureas
  • People who are pregnant or currently breastfeeding
  • People who have had a problem with substance use (excluding marijuana) or alcohol in the past 3 months, as assessed by a standard clinical interview — note that people with a past history of substance or alcohol issues (but not current) may still be considered
  • People who are assessed as being at high immediate risk of suicide, such as having suicidal thoughts with intent to act, as evaluated using a standard safety scale
  • People who work shift work, due to the disruption this causes to the body's natural sleep-wake cycle
  • People who have been diagnosed with certain active sleep disorders, including sleepwalking-type disorders (non-REM arousal disorders), REM sleep behaviour disorder, or narcolepsy
  • People who regularly wake during the night due to a need to urinate
  • People who are known to sleepwalk or physically act out their dreams
  • People who have been diagnosed with, or are suspected of having, dementia
  • People who have a seizure disorder
  • People who are experiencing severe difficulties with thinking or memory, or current psychiatric symptoms serious enough to prevent safe participation — such as active psychosis or imminent risk of suicide

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 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Kerrie L Moreau, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Phone: (720) 885-1950

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
10 September 2025
Est. completion
30 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Pittsburgh Sleep Quality 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: 23 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