No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
342 (estimated)
Sponsor
University of Colorado, Colorado Springs · Other
Who this trial is looking for
This trial is looking for pregnant women with military connections who want to improve their sleep and mental health after giving birth. Participants will use a smart bassinet or a standard bassinet and share their experiences over six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am a pregnant woman with a military affiliation.
I am between 18 and 45 years old.
I can communicate during the screening process.
I have access to a computer, smartphone, or tablet with internet.
I am willing to use the bassinet I am assigned.
I can travel to a local Quest for a blood draw.
You may not be able to join if
I have current depression or suicidal thoughts.
I plan to sleep in the same bed as my infant.
I am under 18 years old or over 45 years old.
I am pregnant with more than one baby.
I have Type 1 diabetes.
I use tobacco.
I have untreated sleep disorders.
I currently take medications for mood or sleep.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest …
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.
Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
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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 …
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.
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