ClinicalTrials.gg
RecruitingNCT07392138Updated Apr 16, 2026

Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring

An observational study in Synchrony, sponsored by University of Turku. Recruiting at 1 site in Finland. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by University of Turku · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2026; still recruiting 6 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
0 Years and older
Sex
All
01

Study summary

Parents and newborns influence each other in a dynamic interaction that can be described as synchrony. Synchrony between a newborn and mother refers to the dynamic and reciprocal adaptation between the newborn and mother. In this synchrony, the mother is highly receptive and sensitive to the newborn's signals, feelings, and needs. The aim of this study is to investigate the physiological and behavioral synchrony between newborns and their mothers, and to investigate the connection between maternal heart rate variability and postpartum depression symptoms in the home environment and to evaluate the suitability of remote monitoring devices for use in the home environment.

The study participants consist of 30 newborns and 30 mothers. The inclusion criteria for newborns are: 1) informed consent from the newborn's parents/guardians 2) the newborn's health status has been confirmed as normal during hospital monitoring, and 3) the newborn is less than one month old. The inclusion criteria for mothers are: 1) ability to participate in Finnish, and 2) the mother has access to an Android smartphone.

Data collection will be carried out using the following remote monitoring methods: Emfit smart mattress, Zoundream Cry analyses technology, Polar Verity Sense sensor, and Empatica EmbracePlus sensor. In addition, data will be collected using background information forms, a maternal stress scale (PSS-4), a diary completed by the mother, a maternal depression questionnaire (EPDS), and questionnaires measuring the suitability of remote monitoring in the home environment, and a thematic interview. In addition, at the end of the data collection phase, the mothers participating in the study will try out the Companion App, which displays sample data on the well-being of newborns, and respond to a questionnaire on the usability of the app.

02

Conditions studied

  • Synchrony
03

In context

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study population consists of mother-newborn pairs.

Eligibility criteria

Inclusion Criteria, mothers:

  • ability to participate in Finnish
  • Android smart phone available

Inclusion Criteria, newborns:

  • received from both parents/guardians
  • the newborn's health has been stated normal during hospital stay
  • the newborn is \< 1-month of age

Exclusion Criteria, both (mother and newborn):

Not meeting the inclusion criteria

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Newborn

    Other: Using monitoring devices

  • Mother

    Other: Using monitoring devices

Interventions

  • OtherUsing monitoring devices

    During the data collection, mother and newborn are using the monitoring devices listed in study description.

06

What researchers measure

Primary outcomes

  1. Physiological synchrony

    Measuring correlation between mother heart rate (mHR (unit: BPM)) and heart rate variability (mHRV (unit ms)) and newborn heart rate (bHR (unit: BPM)) and heart rate variability (bHRV (unit: ms)).

    Time frame: 24 hours

Secondary outcomes

  1. Behavioral synchrony

    Measuring the correlation between mother total sleep duration and duration of different sleep stages and newborn total sleep duration and duration of sleep stages (unit: hours and minutes).

    Time frame: 24 hours

  2. Correlation between mother heart rate variability and depressive symptoms

    Measuring the correlation between mother heart rate variability (mHRV (units: ms)) and depressive symptoms (points from EPDS scale).

    Time frame: Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.

  3. Correlation between mother sleep and depressive symptoms.

    Measuring the correlation between the duration of mother sleep stages (unit: hours and minutes) and depressive symptoms (points from EPDS scale).

    Time frame: Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07392138
Responsible party
Anna Axelin (Professor, University of Turku) — Principal investigator
First posted
Feb 6, 2026
Start date
Apr 13, 2026
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Anna Axelin, Professor
Contact
anmaax@utu.fi
+358405029905

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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