NCT06711809

Brief Summary

During and after pregnancy, a woman's body and brain undergo significant changes that help her adapt to caregiving and emotional needs. However, this period also makes women more susceptible to emotional disorders, such as peripartum depression (PPD), which affects about 10-15% of new mothers. PPD can negatively impact both the mother and her baby, disrupting mood, motivation, and mothering abilities. Hormonal changes and poor sleep are some of the risk factors that might worsen these depressive symptoms. Traditionally, sleep studies on PPD have relied on questionnaires and short-term sleep assessments. With the advent of smartwatches and digital devices, we can now monitor sleep in a home environment over longer periods. Oxytocin, a hormone crucial for childbirth, breastfeeding, and bonding with the baby, is thought to play a role in PPD. Studies suggest that higher levels of oxytocin might be linked to lower levels of postpartum depression, though findings are not always consistent. Oxytocin also affects sleep and is connected to brain areas that regulate reward and motivation. This study aims to explore the relationship between sleep, oxytocin, and reward processing in new mothers. The investigators will include women with varying levels of depressive symptoms and use home-based sleep assessments to gather data. Our goal is to better understand how these factors interact in the postpartum period and how they might influence a mother's mental health and caregiving abilities. The investigators expect that oxytocin levels are reduced in women with higher depressive symptoms and that these reductions are associated with sleep impairments, breastfeeding and altered reward processing.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

November 22, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 22, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

oxytocinperipartum depressionpostpartum depressionsleepsleep assessmentreward processingmotivation

Outcome Measures

Primary Outcomes (6)

  • objective sleep

    Objective sleep measures assessed with tracking devices (Fitbit Inspire; Withings sleep analyser) e.g., total time spent in bed, wake time, wake frequency, sleep stages duration.

    7 consecutive nights

  • subjective sleep

    Subjective sleep assessed by a daily sleep diary.

    7 consecutive days

  • oxytocin levels

    Oxytocin levels assessed with saliva kits.

    7 consecutive days

  • breastfeeding

    Assessment of breastfeeding behavior (onset, frequency and duration) with breastfeeding diaries.

    7 consecutive days

  • bonding

    Bonding of mother and child assessed with questionnaires.

    7 consecutive days

  • reward processing/motivation

    Assessment of effort-based motivation using the effort allocation task.

    7 consecutive days

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Research participants will be recruited in the area of Uppsala, Sweden.

You may qualify if:

  • Age: 18-40
  • Biological sex/gender: female
  • Swedish/English fluency
  • Postpartum phase: 6 weeks to 1 year

You may not qualify if:

  • Age \< 18
  • Neonatal complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Uppsala

Uppsala, Sweden, 751 24, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva samples for salivary oxytocin analysis

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 2, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations