Improving Maternal Sleep and Mental Health

Launched by UNIVERSITY OF COLORADO, COLORADO SPRINGS · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a Smart Bassinet to see if it can help new mothers get better sleep and reduce feelings of depression and anxiety after giving birth. The researchers want to compare how well mothers and their infants sleep when using the Smart Bassinet versus a standard bassinet. They believe that improved sleep for both the mother and baby will lead to fewer mood problems over the first six months after childbirth.

To participate, women must be aged 18 to 45, pregnant with one baby, and have a military connection. Participants will be randomly assigned to use either the Smart Bassinet or the standard one. They’ll fill out monthly online surveys about their sleep and mood, and there will be some blood tests to check for inflammation. This study is important because it aims to find ways to support new mothers’ mental health during a challenging time.

Gender

FEMALE

Eligibility criteria

• 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.