Phase 4 Sleep Disorders Trial, Recruiting NCT06497894 Sponsor: Insel Gruppe AG, University Hospital Bern Condition: Sleep Disorders
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Phase 4 Sleep Disorders Trial, Recruiting

NCT06497894
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:

  • Women who are in the late stage of the menopausal transition, as defined by a specific set of reproductive aging guidelines called STRAW+10
  • People who score above 5 on a standard sleep quality questionnaire called the Pittsburgh Sleep Quality Index, which suggests poor sleep quality
  • People who score above 7 on a standard insomnia questionnaire called the Insomnia Severity Index, which suggests moderate to severe insomnia symptoms
  • People who score 4 or more points on the physical symptom section of a menopause symptom rating scale called the Menopause Rating Scale II
  • People who are willing to use hormone replacement therapy (HRT) to help manage menopause symptoms

Who may not be able to join:

  • People who have other sleep or wakefulness disorders as identified by recognised diagnostic guidelines and standard sleep questionnaires
  • People who have an untreated hormonal condition
  • People with a BMI of 30 or above (classified as obesity)
  • People who are currently receiving psychotherapy
  • People who are currently taking psychiatric medications or medications regularly used for sleep
  • People who have previously tried a specific talking therapy for insomnia (called CBT-I) without success
  • People who have a psychiatric illness
  • People who smoke 7 or more cigarettes per day, drink more than 2 standard alcoholic drinks per day as defined by the WHO, or use other substances
  • People who work shift work
  • People who have travelled across multiple time zones on long-haul flights within the past 3 months
  • People who are pregnant or breastfeeding
  • People for whom hormone replacement therapy is medically unsuitable, as determined by Swiss medication guidelines
  • People who are unable to follow the study procedures or do not have sufficient knowledge of the language the study is conducted in
  • People who are not able to give informed consent to participate

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 14 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: Petra Stute, Prof., University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Phone: +41 31 632 1010

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
Sponsor
Insel Gruppe AG, University Hospital Bern
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
1 July 2026

Where this trial is recruiting

🇨🇭 Switzerland

Primary endpoints

Reduction of Insomnia Severity

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: 14 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