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Improving Maternal Sleep and Mental Health with Smart Bassinet

This study is testing if a Smart Bassinet (SNOO) can help prevent or lessen postpartum depression and anxiety by improving sleep for new mothers and their babies. Researchers will compare the SNOO to a standard bassinet (HALO). They will look at mothers' moods and sleep, and babies' sleep, over six months. You might be able to join if you are a pregnant woman, 18-45 years old, with a military connection, and expecting one baby. The study is looking for 342 participants. The current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two groups: one using the SNOO Smart Bassinet and another using the HALO bassinet, with 342 participants.
What's involved
You would complete online surveys monthly for 6 months and have a blood draw at a local Quest. You would also collect sleep data for one week each month.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months postpartum to measure maternal mood, maternal sleep, and infant sleep.

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NCT06544941

Improving Maternal Sleep and Mental Health

Recruiting
NAAges 18–45InterventionalPrevention
University of Colorado, Colorado Springs
~342 participants
Updated 2025-02-10 on ClinicalTrials.gov
What's tested:Smart BassinetHALO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal Mood
Measured over 0-6 months postpartum
+3 more outcomes measured

Conditions

Postpartum Depression
Postpartum Anxiety
Sleep Disturbance
Infant Behavior
Maternal Behavior
Inflammation
Military Family

Explore related trials

Postpartum anxietyPostpartum DepressionSleep Disorder

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Michele L Okun · PRINCIPAL_INVESTIGATOR · University of Colorado, Colorado Springs

Who to contact

Michele L Okun, Ph.D.
[email protected]
412-302-8030
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maternal Mood0-6 months postpartum

    Assessment of depressive and anxiety symptoms across the first 6 months postpartum

  • Maternal Sleep0-6 months postpartum

    Assessment of sleep across the first 6 months postpartum

  • Infant Sleep0-6 months postpartum

    Assessment of infant sleep across the first 6 months postpartum

  • Maternal Inflammationlate pregnancy, 3 & 6 months postpartum

    Assessment of changes in maternal inflammation