SynchronyNCT07392138
Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring
An observational study of Synchrony, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Synchrony
- What is being tested?
- Using monitoring devices
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 13 Apr 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population consists of mother-newborn pairs.
Who may be able to join
- ability to participate in Finnish
- Android smart phone available
- received informed consent from both parents/guardians
- the newborn's health has been stated normal during hospital stay
- the newborn is < 1-month of age
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Anna Axelin, Professor, +358405029905, anmaax@utu.fi
About this study
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.
- Conditions
- Synchrony
- Being tested
- Using monitoring devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using monitoring devicesOther
During the data collection, mother and newborn are using the monitoring devices listed in study description.
| Study group | Role | What they receive |
|---|---|---|
| Newborn | Not described Receives: Other: Using monitoring devices | |
| Mother | Not described Receives: Other: Using monitoring devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 24 hours
Secondary outcomes (3)
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).
Measured: 24 hours
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).
Measured: Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.
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).
Measured: Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start13 Apr 2026
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynchronyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Axelin, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392138
- Sponsor's protocol ID
- #476745
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring
- ClinicalTrials.gov ID
- NCT07392138
- Acronym / sponsor ID
- #476745
- Conditions
- Synchrony
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborn | – | Other: Using monitoring devices |
| Mother | – | Other: Using monitoring devices |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population consists of mother-newborn pairs.
Key inclusion criteria (5 listed)
- ability to participate in Finnish
- Android smart phone available
- received informed consent from both parents/guardians
- the newborn's health has been stated normal during hospital stay
- the newborn is < 1-month of age
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using monitoring devicesDuring the data collection, mother and newborn are using the monitoring devices listed in study description. | Other | Mother, Newborn |
Primary outcome
Physiological synchrony
Time frame: 24 hours
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)).
3 secondary outcomes
Behavioral synchrony
Time frame: 24 hours
Correlation between mother heart rate variability and depressive symptoms
Time frame: Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.
Correlation between mother sleep and depressive symptoms.
Time frame: Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Synchrony, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Axelin, Professor (+358405029905, anmaax@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological synchrony (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.