Improving Maternal Sleep and Mental Health
A legfontosabb adatok
- Ki végzi
- University of Colorado, Colorado Springs
- Hol
- Colorado Springs (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 342 fő, tervezett
- Kezdés
- 2025. jan. 15.
- Várható befejezés
- 2028. jún.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Smart Bassinet
- HALO
- A regiszteradat frissítve
- 2025. február 10.
Ki vehet részt
- Életkor
- 18 év – 45 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 13 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation
- 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
- 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
- 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
- Under the age of 18 years or > 45 years. The goal is to include women of childbearing age
- Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet
- Tobacco use (current). Smoking is associated with poor sleep and inflammation
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 45 év között vagy?
Helyszínek itt: Egyesült Államok
- University of Colorado Colorado SpringsColorado Springs, Egyesült ÁllamokContact: Michele L Okun, Ph.D.Résztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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)). 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 question[s] it aims to answer [is/are]:
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Smart Bassinet (SB)A vizsgált kezelés
The SB responds to an infant who is fussing or crying by initiating "swaying" movement and "shushing" sounds with white noise that incrementally increase until the infant calms or the caregiver shuts it off. It will help babies transition into life outside of the womb with ease, enabling them to feel safe and secure, which translates to more sleep.
Kezelés: Smart Bassinet
- HALO Bassinet (TAU)Már használt kezelés, összehasonlításként
The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.
Kezelés: HALO
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet
- Illeszkedési kérdések
- Forrás: NCT06544941: ki vehet részt
- A regiszteradat frissítve
- 2025. február 10.