Using a Smart Bassinet to Improve Maternal Sleep and Mental Health
Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet
NA · University of Colorado, Colorado Springs · NCT06544941
This study is testing if a Smart Bassinet can help new mothers and their babies sleep better, which might also improve the mothers' mental health after giving birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Colorado, Colorado Springs (other) |
| Locations | 1 site (Colorado Springs, Colorado) |
| Trial ID | NCT06544941 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45 with a military affiliation who are expecting a singleton birth.
Not a fit: Patients with current depression, suicidal ideation, or those planning to co-sleep with their infant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve maternal mental health and infant sleep, reducing the incidence of postpartum depression and anxiety.
How similar studies have performed: While this approach is novel in its specific application, previous studies have indicated that interventions targeting sleep can positively influence maternal mental health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Colorado Springs, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Depression, Postpartum Anxiety, Sleep Disturbance, Infant Behavior, Maternal Behavior, Inflammation, Military Family, sleep