Using a Smart Bassinet to Improve Maternal Sleep and Mental Health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a Smart Bassinet in enhancing sleep for both mothers and infants, potentially reducing postpartum mood disorders. A total of 342 mother-infant pairs will be randomly assigned to either the Smart Bassinet or a standard bassinet for a duration of six months. Participants will complete monthly online surveys regarding sleep patterns and maternal mental health, while also providing objective sleep data. The study will also explore maternal biomarkers related to postpartum depression, assessing the impact of the intervention on immune dysregulation and inflammation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant women with a singleton gestation who have a military affiliation
* Ages 18-45 years
* Ability to communicate during the screening process
* Access to a computer, smart phone or tablet with internet service
* Willing to use bassinet they are randomized to
* Willing to travel to a local Quest for blood draw

Exclusion Criteria:

* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.
* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.
* Under the age of 18 years or \> 45 years. The goal is to include women of childbearing age.
* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.
* Tobacco use (current). Smoking is associated with poor sleep and inflammation.
* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.
* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.

Where it's running

• University of Colorado Colorado Springs
  Colorado Springs, Colorado, United States Recruiting

Study contacts

• Principal investigator: Michele L Okun — University of Colorado, Colorado Springs
• Study coordinator: Michele L Okun, Ph.D.
• Email: mokun@uccs.edu
• Phone: 412-302-8030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.