Sleep Disorders Trial, Recruiting NCT07345065 Sponsor: De deyne Manon Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07345065
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:

  • Women who have had a single-baby pregnancy (not twins or more)
  • Women who are between 4 and 12 months after giving birth to their first child
  • Women who have sleep difficulties, specifically: trouble falling asleep, staying asleep, or waking up too early — AND these sleep issues cause problems during the day, are not caused by the baby or a partner, and happen at least 3 nights per week for at least 3 months. A short questionnaire score is also used to confirm this (confirm with trial site)
  • Women who have access to a phone, computer, and email
  • Women who can read and understand Dutch well enough to follow the therapy content, fill in questionnaires, and understand instructions

Who may not be able to join:

  • Women who are currently pregnant
  • Women who work shift work
  • Women who have been diagnosed with a serious mental health condition, such as bipolar disorder, post-traumatic stress disorder, or psychosis
  • Women who have a current severe or untreated sleep disorder, such as narcolepsy, restless legs syndrome, or a circadian rhythm disorder
  • Women who have an unstable medical condition that may be affecting their sleep
  • Women who have completed a specific talking therapy for insomnia (called Cognitive Behavioural Therapy for Insomnia, or CBTi) within the past 6 months
  • Women whose sleep problems are caused by their baby waking more than three times per night, for more than 30 minutes at a time, and needing a parent's help to get back to sleep

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 19 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: +32498512698

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
De deyne Manon
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
1 April 2028

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Insomnia Severity; Economic evaluations: Medical Consumption; Economic evaluations: Productivity Cost; Economic evaluations: Health-related quality of life

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: 19 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