Sleep Disorders Trial, Recruiting NCT05759065 Sponsor: Brigham and Women's Hospital Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05759065
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 are 18 years of age or older
  • People who have been diagnosed with insomnia based on standard medical diagnostic criteria (DSM-5)
  • People whose insomnia severity score is greater than 10 on a standard measurement scale
  • People who receive healthcare through a publicly-supported insurance program (such as Commonwealth Connector or MassHealth), or — for people over 65 on Medicare — those whose insurance coverage before Medicare may be reviewed by the trial site
  • People who identify as a racial or ethnic minority (this criterion may apply as an alternative to the insurance requirement — confirm with trial site)
  • People who have the ability to give informed consent, as assessed by a standard test (SDT score below 9)

Who may not be able to join:

  • People with untreated, current severe depression (based on a standard questionnaire score)
  • People with a history of bipolar disorder or psychosis
  • People with current issues related to alcohol or drug misuse, as identified by standard screening tools
  • People with very high levels of daytime sleepiness, as measured by a standard scale
  • People who have had a seizure within the past year
  • People whose main sleep period falls outside the hours of 8pm to 11am
  • People who regularly work night shifts (five or more overnight shifts per month, defined as working between midnight and 5am)
  • People who have already been diagnosed with moderate to severe sleep apnea that has not been treated
  • People with a serious medical condition that may require hospitalisation in the next 6 months
  • People who show signs of active suicidal thoughts during screening
  • People who are pregnant or planning to become pregnant
  • People already participating in other studies that the trial's lead researcher determines could affect the safety or benefit of this trial's treatment

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
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

Phone: 857-307-0355

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
2 April 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Insomnia severity index, ISI

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