BreastfeedingLactogameNCT07800078
Evaluation of a Wearable Technology to Support Breastfeeding Women
A study testing Breast Milk-Sensitive Wearable Technology in people with Breastfeeding, run by Özlem Ülkü BULUT at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breast Milk-Sensitive Wearable Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Sep 2027
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45 years
- Currently breastfeeding
- Having an infant aged 0-6 months
- Willing to use the wearable technology and accompanying mobile application for 15 days
- Able to express breast milk for comparison with sensor measurements
- Voluntarily agreeing to participate in the study
Who cannot join
- Having a medical condition that prevents breastfeeding or breast milk expression
- Having an active breast or nipple condition that prevents the use of the wearable prototype
- Being unable to use the wearable technology or mobile application during the study period
- Withdrawing consent at any stage of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Breast Milk-sensitive Wearable Technology and Evaluation of Its Effects Through the Experiences of Breastfeeding Women
This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. The study will also evaluate women's experiences, satisfaction, perceived usefulness, and ease of use of the wearable prototype and its mobile application. The technology is intended for monitoring and support purposes and will not be used for diagnosis, treatment, or clinical decision-making.
- Conditions
- Breastfeeding
- Being tested
- Breast Milk-Sensitive Wearable Technology
- Keywords
- Wearable Technology, Breast Milk, Breastfeeding Support, Digital Health, Milk Flow, User Experience
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Milk-Sensitive Wearable TechnologyDevice
Participants will use a breast milk-sensitive wearable prototype integrated with a mobile application. The wearable technology collects sensor-based measurements related to breast milk fullness and milk flow. Sensor measurements will be compared with the amount of breast milk obtained through breast pumping. Participants' experiences, satisfaction, perceived usefulness, and ease of use of the wearable technology and mobile application will also be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Breastfeeding Support Technology | Experimental | Participants will use the wearable prototype and its accompanying mobile application. Sensor measurements obtained during use will be evaluated and compared with the amount of breast milk obtained through breast pumping. Participants' experiences with the technology will also be assessed. Receives: Device: Breast Milk-Sensitive Wearable Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical Sensor Signals Obtained From the Wearable Prototype
The wearable sensor system will acquire and analyze sensor signals to generate a Breast Milk Fullness Index ranging from 0 to 100. Higher values indicate greater estimated breast milk fullness. Measurements will be obtained in relation to breastfeeding and/or breast pumping sessions and compared with reference measurements of milk removal.
Measured: During the 15-day intervention period
Milk Flow Pattern Parameters Measured by the Wearable Sensor System
Milk flow-related signal patterns will be acquired and analyzed by the LactoGame wearable sensor system during breastfeeding and/or breast pumping. Quantitative system-derived parameters, including average and peak signal characteristics, will be used to characterize milk flow patterns.
Measured: During the 15-day intervention period
Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form
Expressed breast milk volume will be recorded using the Breast Milk Expression Volume Record Form. For each pumping session, the amount of breast milk obtained will be recorded in milliliters (mL), together with breast side, expression method, and expression duration. Expressed milk volume will be used as a reference measurement for comparison with sensor-derived measurements.
Measured: During the 15-day intervention period
Secondary outcomes (1)
User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form
User experience and satisfaction will be assessed using the researcher-developed 14-item User Experience and Satisfaction Evaluation Form. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70, with higher scores indicating a more positive user experience and greater satisfaction with the wearable prototype and mobile application. The form also includes three open-ended questions to obtain additional qualitative feedback.
Measured: At the end of the 15-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Özlem Ülkü BULUT
- Sponsor type
- Other government
- Collaborators
- Lokman Hekim University
- Responsible party
- Sponsor-investigator, Özlem Ülkü BULUT, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800078
- Sponsor's protocol ID
- LactoGameWear01
- Acronym
- Lactogame
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Breast Milk-sensitive Wearable Technology and Evaluation of Its Effects Through the Experiences of Breastfeeding Women
- ClinicalTrials.gov ID
- NCT07800078
- Acronym / sponsor ID
- Lactogame / LactoGameWear01
- Conditions
- Breastfeeding
- Keywords
- Wearable Technology, Breast Milk, Breastfeeding Support, Digital Health, Milk Flow, User Experience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Özlem Ülkü BULUTOther government
- Collaborators
- Lokman Hekim University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Sep 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.
This study aims to evaluate a wearable technology developed to support breastfeeding women. The study will assess the performance of sensors in the wearable prototype for monitoring breast milk fullness and milk flow and compare the sensor measurements with the amount of breast milk obtained through breast pumping. The study will also evaluate women's experiences, satisfaction, perceived usefulness, and ease of use of the wearable prototype and its mobile application. The technology is intended for monitoring and support purposes and will not be used for diagnosis, treatment, or clinical decision-making.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Breastfeeding Support Technology | Experimental | Device: Breast Milk-Sensitive Wearable TechnologyParticipants will use the wearable prototype and its accompanying mobile application. Sensor measurements obtained during use will be evaluated and compared with the amount of breast milk obtained through breast pumping. Participants' experiences with the technology will also be assessed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-45 years
- Currently breastfeeding
- Having an infant aged 0-6 months
- Willing to use the wearable technology and accompanying mobile application for 15 days
- Able to express breast milk for comparison with sensor measurements
Key exclusion criteria (4 listed)
- Having a medical condition that prevents breastfeeding or breast milk expression
- Having an active breast or nipple condition that prevents the use of the wearable prototype
- Being unable to use the wearable technology or mobile application during the study period
- Withdrawing consent at any stage of the study
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 |
|---|---|---|
| Breast Milk-Sensitive Wearable TechnologyParticipants will use a breast milk-sensitive wearable prototype integrated with a mobile application. The wearable technology collects sensor-based measurements related to breast milk fullness and milk flow. Sensor measurements will be compared with the amount of breast milk obtained through breast pumping. Participants' experiences, satisfaction, perceived usefulness, and ease of use of the wearable technology and mobile application will also be evaluated. | Device | Wearable Breastfeeding Support Technology |
Primary outcome
Electrical Sensor Signals Obtained From the Wearable Prototype
Time frame: During the 15-day intervention period
The wearable sensor system will acquire and analyze sensor signals to generate a Breast Milk Fullness Index ranging from 0 to 100. Higher values indicate greater estimated breast milk fullness. Measurements will be obtained in relation to breastfeeding and/or breast pumping sessions and compared with reference measurements of milk removal.
Milk Flow Pattern Parameters Measured by the Wearable Sensor System
Time frame: During the 15-day intervention period
Milk flow-related signal patterns will be acquired and analyzed by the LactoGame wearable sensor system during breastfeeding and/or breast pumping. Quantitative system-derived parameters, including average and peak signal characteristics, will be used to characterize milk flow patterns.
Expressed Breast Milk Volume Assessed Using the Breast Milk Expression Volume Record Form
Time frame: During the 15-day intervention period
Expressed breast milk volume will be recorded using the Breast Milk Expression Volume Record Form. For each pumping session, the amount of breast milk obtained will be recorded in milliliters (mL), together with breast side, expression method, and expression duration. Expressed milk volume will be used as a reference measurement for comparison with sensor-derived measurements.
1 secondary outcome
User Experience and Satisfaction Assessed Using the User Experience and Satisfaction Evaluation Form
Time frame: At the end of the 15-day intervention period
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 2 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Milk-Sensitive Wearable Technology in people with Breastfeeding, run by Özlem Ülkü BULUT at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Sep 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical Sensor Signals Obtained From the Wearable Prototype (time frame: During the 15-day intervention period). The study lists 3 primary outcomes in all. 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 2 Sep 2026.