Phase 4 Sleep Disorders Trial, Recruiting NCT07018557 Sponsor: University of Sao Paulo Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT07018557
Recruiting Phase 4

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:

  • Adults between 30 and 75 years old
  • People with a body mass index (a measure of body weight relative to height) below 40
  • People who are available and willing to take part in the study
  • People who have a history of high blood pressure and are already receiving regular treatment for it, with blood pressure readings within a specific moderate range (systolic between 130–160 and diastolic between 80–100 mmHg) (confirm with trial site)

Who may not be able to join:

  • People who currently use benzodiazepines (a type of sedative or anxiety medication) or so-called "Z drugs" (sleep medications such as zolpidem)
  • People who work night shifts
  • People with a history of severe chronic lung disease (COPD)
  • People with heart failure where the heart is pumping at a significantly reduced capacity (confirmed by a heart scan)
  • People who have previously had a stroke
  • People with severe anxiety (based on a specific anxiety questionnaire score) or severe depression (based on a specific depression scale)
  • People with severe liver disease
  • People with alcohol misuse or dependency
  • People with advanced kidney disease (stage 4 or 5, based on kidney filtering function)
  • People currently taking a type of water tablet called loop diuretics
  • People with type 1 diabetes
  • People with poorly controlled type 2 diabetes (based on a blood sugar marker called glycated haemoglobin being above 10%)
  • People with urinary incontinence (difficulty controlling bladder leakage)
  • People with prostate-related urinary problems (prostatism)
  • People with a current or active cancer diagnosis
  • People who are pregnant
  • People with complex sleep-related behaviours or a history of suicidal behaviour

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Luciano F. Drager, MD, PhD, University of Sao Paulo Medical School

Phone: +5511988027887

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 4
Registry
ClinicalTrials.gov
Start date
4 June 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)

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