Postpartum Depression study: Smart Bassinet vs HALO
Official title Improving Maternal Sleep and Mental Health
ClinicalTrials.gov ID: NCT06544941
What this study is testing
- What it's testing
- This study wants to find out if using a smart bassinet improves sleep for both the baby and the mother. It also checks if better sleep leads to fewer symptoms of depression and anxiety after birth.
- Who it's for
- The study is looking for pregnant women who are connected to the military.
- What's involved
- Participants will use either a smart bassinet or a standard bassinet. They will fill out online surveys every month, wear a wristband to track sleep for one week each month, and give blood samples at enrollment and at 3 and 6 months after birth.
- Time commitment
- The study lasts for 6 months after the baby is born and requires monthly online surveys and sleep tracking.
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.
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).
- 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.
- 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.
- 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 is enrolling
- Colorado Springs, Colorado, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Colorado Springs, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.