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New treatment option for Postpartum Depression
Official title Improving Maternal Sleep and Mental Health
ClinicalTrials.gov ID: NCT06544941
What this study is testing
- What it's testing
- 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)).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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 assigned by chance to
You likely can't join if
- Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section...
- 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...
- 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...
See the full eligibility 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 assigned by chance to
- Willing to travel to a local Quest for blood draw
- 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...
- 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...
- 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...
- Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.