The investigators propose to conduct a 2-arm randomized controlled trial (RCT) to compare
infant and maternal sleep of infants who use the SB or a standard commercially available
bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)).
The primary objective of this proposal is to randomly assign mother-infant dyads (N =
342) to the SB or the TAU condition and follow them monthly for 6 months. Mothers will
complete online surveys monthly regarding infant sleep and behavior, maternal sleep, and
maternal depressive symptoms. Prospective subjective and objective sleep data will also
be collected from mother and infant for one week each month. This study represents the
first empirical study to assess the efficacy of the SB to promote efficient infant sleep,
and to assess longitudinal effects on maternal postpartum sleep and mood symptoms. This
work is essential since few effective interventions are available that support infant
sleep. A secondary objective is to explore maternal biomarkers of PPD, including markers
of inflammation and epigenetic biomarkers, and determine if the SB intervention alters
immune dysregulation and the risk associated with epigenetic biomarkers of PPD. The
rationale stems from evidence regarding dysregulation of the immune system and
inflammatory activity as potential mediating pathways between sleep disturbances and
health.
This proposal will address the following aims:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. Hypothesis 1a:
Infants who sleep in the SB will have better sleep (i.e., diary and Brief Infant Sleep
Questionnaire as maternally reported) compared to TAU. Outcomes will include maternally
reported sleep duration, awakenings, as well as objective assessed (actigraphy) wake
after sleep onset (WASO), and sleep onset latency (SOL). Hypothesis 1b: Mothers of
infants who sleep in the SB will have better subjectively reported (i.e., diary and
Pittsburgh Sleep Quality Index) and objectively assessed (actigraphy) sleep compared to
TAU. Outcomes will be the same as the infants.
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. Hypothesis 2a: Mothers of infants who
sleep in the SB will have fewer postpartum depressive symptoms over time (i.e., Edinburgh
Postnatal Depression Scale) compared to TAU. Hypothesis 2b: The SB improves infant sleep,
which then predicts better maternal sleep, and thereby predicts lower maternal depressive
symptoms.
Aim 3: Compare trajectory of immune system function from late pregnancy through
postpartum between PPD and non-PPD and between SB and TAU groups. Hypothesis 3:
Peripheral cytokines, immune cells, and stimulated cytokine profiles of women with PPD
assessed in late pregnancy, 3- and 6- months postpartum, will indicate greater innate
immune activity compared to those who do not develop PPD. Hypothesis 3b: Mothers of
infants who sleep in the SB will exhibit less innate immune dysfunction than TAU mothers.
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.
Participants. Eligible Pregnant women (N = 342) will be enrolled and randomly assigned to
SB or TAU stratified by epigenetic status in the late 3rd trimester and followed
longitudinally every month for 6 months. Inclusion criteria: History of depression;
singleton gestation; 18-45 years of age; ability to communicate during the screening
process; access to a computer, responsive phone, or tablet with internet service; and
willing to use the bassinet they are randomized to. Exclusion criteria: clinical
confirmation of any current psychopathology (depression, anxiety, suicidal intent,
bipolar disorder, etc.), use of psychotropic or sleep medications, multiple gestations,
pregnancy/birth complications that would interfere with bassinet use, plans to co-sleep
with infant exclusively, tobacco, alcohol, or substance abuse during pregnancy.
Self-reported, untreated comorbid sleep disorders, including narcolepsy, periodic leg
movement disorder, and/or obstructive sleep apnea.
Initial clinical assessment of depression: Psychopathology will be assessed over the
phone using The Structured Clinical Interview for DSM-5 Disorders (SCID-5-CV).
Randomization. Mothers-infant dyads (up to N = 342) will be randomly assigned to
conditions by using a random number generating program found on a widely used and
reputable website (www.randomizer.org)". This will further allow for comparability
between the SB and current usual care/common sleep arrangements. The investigators will
perform 1:1 randomization, stratifying for epigenetic status. The SB will be shipped to
participants and returned at the expense of Happiest Baby, Inc. TAU participants will be
shipped the Halo Bassinest Swivel Sleeper bassinet.
Data Collection. For each assessment, all participants will receive an email with a
REDCap link for online data collection. To mitigate and minimize the possibility of
missing data in the measures, electronic questionnaires will be programmed to prevent
skipping questions. In addition, participants will receive a monthly package containing
two actigraphs, maternal sleep diaries, the Baby's Day Diary, a certified blood mailer
with tubes, and a prepaid return envelope.