Sleep Disorders Trial, Recruiting NCT07558616 Sponsor: Xuanwu Hospital, Beijing Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07558616
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 between 18 and 65 years who have been diagnosed with either a neuromyelitis optica spectrum disorder (NMOSD) or multiple sclerosis (MS) according to specific Chinese diagnostic guidelines, and who also have insomnia — OR people aged between 18 and 65 who have been diagnosed with long-term (chronic) primary insomnia according to recognised international diagnostic standards.
  • People who have trouble falling asleep, staying asleep, or who wake too early, on at least 3 nights per week, and have had this problem for more than 3 months.
  • People whose sleep problems are causing significant difficulty with daytime functioning, based on a specific sleep quality questionnaire score (confirm with trial site).
  • People who have not taken any sleeping tablets or insomnia medications for at least the past 4 months.
  • Women aged 18–50 who agree to use effective contraception for the entire duration of the study.
  • People who agree not to receive any other medication or non-medication treatments for insomnia during the study period.
  • People who are willing to participate and sign a consent form.

Who may not be able to join:

  • People who have had a relapse of their condition within the past month.
  • People whose medications have been changed in the past month, or who have recently received electroconvulsive therapy, transcranial magnetic stimulation, or similar brain stimulation treatments.
  • People who are currently taking part in, or have taken part in, another clinical trial within the past month.
  • People who have a cochlear implant, a cardiac pacemaker, or any implanted device in the brain.
  • People who have broken or damaged skin at the area where electrodes would be placed, or who have a known allergy to electrode gel or adhesive.
  • People with a history of brain conditions such as epilepsy, hydrocephalus, brain tumours, head injury, or brain infection.
  • Women who are pregnant, breastfeeding, or planning to become pregnant soon.
  • People who score at a concerning level on the suicide-related question of a standard depression scale, or who have a serious co-existing mental health condition (confirm with trial site).
  • People with serious or unstable physical health conditions affecting major organs or body systems.
  • People who regularly work night shifts.
  • People who have other sleep disorders in addition to insomnia.
  • People whose ability to cooperate with treatment, follow-up appointments, or data collection (including brain scans and EEG recordings) is considered insufficient.
  • People whom the trial investigators consider unsuitable for participation 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 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: Junwei Hao, Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China

Phone: +86 135 0405 1368

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Xuanwu Hospital, Beijing
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
31 July 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The change in Pittsburgh Sleep Quality Index (PSQI) scores

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