Phase 2 Sleep Disorders Trial, Recruiting
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 who are pregnant with one baby, between 14 and 31 weeks along at the time of screening
- People who have been diagnosed with Insomnia Disorder according to standard psychiatric guidelines, lasting at least one month
- People whose insomnia scores at least 11 on a standard insomnia rating scale (the Insomnia Severity Index)
- People whose score on a standard depression screening tool for pregnancy (the Edinburgh Postnatal Depression Scale) is below 13 at screening
- People who do not currently have a diagnosis of Major Depression
- People who have reliable internet access to take part in treatment sessions and assessments
- People who are not currently receiving any therapy for major depression or insomnia
- People aged 18 or older
Who may not be able to join:
- People with a high-risk pregnancy, such as pre-eclampsia or placenta previa with bleeding, or other conditions considered a serious risk to the mother or baby (note: high blood pressure and diabetes alone do not automatically exclude someone — confirm with trial site)
- People who are currently experiencing active thoughts of suicide with intent to act
- People who work night shifts or rotating shifts, or who expect to travel across three or more time zones within the two months following their initial screening
- People who have restless legs syndrome that is currently untreated (people receiving treatment for restless legs syndrome may still be considered)
- People with excessive daytime sleepiness, scoring above 15 on a standard sleepiness rating scale (the Epworth Sleepiness Scale)
- People with an uncontrolled sleep disorder or mental health condition that would make sleep restriction unsafe, such as narcolepsy, bipolar disorder, or epilepsy
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.
Contact this trial
Principal Investigator: David A Kalmbach, PhD, Henry Ford Health
Phone: 248-325-3938
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
Where this trial is recruiting
Primary endpoints
Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms.; Comparative effectiveness of PUMAS and standard care on prevention of perinatal depression.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.