Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544941
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Improving Maternal Sleep and Mental Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Maternal Mental Health in Military-Affiliated Pregnant Women Effectiveness of a Smart Bassinet
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHINE
Brief Summary:
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to preventmitigate postpartum mood disorders by augmenting maternal sleep andor 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 30 usualtraditional 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 questions it aims to answer isare
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
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
Detailed Description:
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 30 usualtraditional 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 ie 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 ie 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 ie 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 pregnancybirth 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 andor 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 wwwrandomizerorg This will further allow for comparability between the SB and current usual carecommon sleep arrangements The investigators will perform 11 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 Babys Day Diary a certified blood mailer with tubes and a prepaid return envelope
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 ie 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 ie 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 ie 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 pregnancybirth 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 andor 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 wwwrandomizerorg This will further allow for comparability between the SB and current usual carecommon sleep arrangements The investigators will perform 11 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 Babys Day Diary a certified blood mailer with tubes and a prepaid return envelope
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None