Sleep Disorders Trial, Recruiting NCT07417813 Sponsor: Shanghai Mental Health Center Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07417813
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 aged 18 or older, of any gender
  • People who have been diagnosed with a mental health condition of any type, based on standard diagnostic guidelines (called DSM-5)
  • People whose insomnia has been rated at a score of 11 or higher on a standard sleep questionnaire called the Insomnia Severity Index (ISI)
  • People who have at least 7 hours available for sleep each night
  • People who are able to attend assessments and follow-up appointments over a 2-month period
  • People who have agreed to take part and signed a consent form
  • People whose treating doctor has determined that the sleep medication lemborexant is an appropriate treatment option for them

Who may not be able to join:

  • People whose mental health condition is currently in an acute (severe or crisis) phase, or whose other psychiatric medications cannot be kept at a stable dose during the study
  • People currently using two or more different medications from a group of sleep drugs known as benzodiazepine receptor agonists (BZRAs) at the same time
  • People who have previously used a type of sleep medication called a dual orexin receptor antagonist (DORA) continuously for more than one week (confirm with trial site)
  • People assessed by the research team as having a clear suicide attempt, plan, or high suicide risk
  • People who are pregnant or breastfeeding
  • People who have a condition called narcolepsy (a sleep disorder involving uncontrollable episodes of sleep)
  • People who have severe liver disease or liver failure
  • People who currently have severe or unstable heart, lung, digestive, or other serious health conditions
  • People the research team considers unsuitable for any other reason

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
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: 18017311500

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
Sponsor
Shanghai Mental Health Center
Registry
ClinicalTrials.gov
Start date
24 January 2026
Est. completion
31 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Insomnia Severity Index (ISI) Score from Baseline

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