Healty BabiesNCT05175560
Baby Breathing Monitoring @Home
An observational study of Healty Babies and 3 Weeks - 3 Months Old, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial summary
To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology. In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting. Read more about this study
- Who is it for?
- Ages 3 weeks to 4 months
- Conditions the study is for
- Healty Babies, 3 Weeks - 3 Months Old
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Feb 2022to 10 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 weeks to 4 months
- All sexes
- Child
Study population: healthy infants and their parents
Who may be able to join
- Parents or caregivers :
- Have a baby aged >3 weeks to ~3-4 months (who is not yet able to role over; see exclusion criteria);
- Have a baby who sleeps in its own bed (i.e. different sleeping surface than parents; same room is allowed);
- Live in the Netherlands;.
- Are able to speak and read Dutch or English.
Who cannot join
- Parents or caregivers
- with a baby who can already roll over (belly to back and back to belly);
- with a baby who is under supervision of an HCP because of health, feeding or developmental problems ;
- are unwilling or unable to provide informed consent on behalf of themselves, their baby and siblings;
- are unwilling or unable to comply with the study requirements;
- do not give permission to use their, or that of potential siblings, audio-video image data recorded during the study as described in the information letter and privacy notice;
- are not able to fill in the questionnaires and baby sleep diary.
Trial locations and contacts
1 site in 1 country.
About this study
To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology.
In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting.
Read more
The data collection will be divided in several sub-studies, either e.g. matching different development steps in the development of the algorithm or focusing on a specific baby population (e.g. specific age range). In general, babies will be monitored (audio, video, activity) for 24 -48 hours under their habitual sleeping conditions.
Step 1: 3 full data sets will be recorded of babies in bed aged 3 weeks to about 3-4 months, who are not able to turn over yet. Data will be analyzed and study set-up will be checked. Parents will be asked to keep a baby sleep diary and a questionnaire will be filled in at the start, with questions regarding the sleep behavior of their child. At the end, parents will be asked to fill in a questionnaire with sleep-related and feedback questions.
In step 2, 5 full data sets will be collected following the same procedure as step 1.
In step 3 12 full data sets will be collected following the same procedure as step 1.
After each step, the study setup including the algorithms, will be reviewed based on the obtained data. All modifications to this protocol will be submitted as amendments.
After step 1 and 2, the Mother and Child Care Business unit of Philips and other relevant stakeholders will be updated on the progress and findings by means of a (short) meeting and PowerPoint slides.
After step 3, a report will be written. The PowerPoint slides shared after Step 1 and 2 will be incorporated in this report.
Read the detailed description
Procedures Phone call
During the Phone call the investigators will:
- explain the study setup
- explain the exclusion and inclusion criteria. The criteria will not be verified until visit 1.
- if the parents or caregivers agree, an appointment will be made for visit 1
- Home visit 1 - about 45 min During the first home visit the investigators will: <!-- -->
- a. make introductions; <!-- -->
- b. explain the study again, if necessary, and answer questions; 1c. together with the subject's parents or caregivers sign the informed consent form belonging to this study;
- confirm the inclusion and exclusion criteria
- Complete the BISK questionnaire (investigator will ask questions to parent and report answers in CRF) 1d. Provide parents a baby sleep diary and instruct them to complete it; 1e. place the study setup in the room the baby mainly sleeps in; 1f. plan the second home visit. 2. During the study (2 consecutive days, including the nights) The setup will monitor the baby's bed, and the baby when the baby is in bed. After the setup is turned on, during Home Visit 1, it will record continuously for about two days (during day and night), until the investigator comes back to pick the setup up (see also Home Visit 2, below). The recording happens automatically; subject's parents or caregivers do not need to do anything with the setup.
The investigators will ask the parents or caregivers to keep a diary of the baby's (sleeping) behavior and to note information of behavior influencing the baby's sleep (e.g. baby being ill, not feeding well) during the recording period or if there was anything out of the ordinary with the setup (siblings fidgeting with it, power outings etc.).
In case of emergency, the recording can be stopped by pulling the electrical cord from the socket.
- Home visit 2 - ~30 min
During the second home visit, the investigators will:
3a. ask how the study went, and if the parents or caregivers have any feedback for the investigators (close out questionnaire, investigator will ask questions to parent and report answers in CRF); 3b. review the sleep diary for omissions 3c. Check the end time and study setup 3d. pick up the test setup.
After completion of the participation, the investigator will notify the recruitment agency to arrange the compensation.
Devices used:
Survey/questionnaire: Baby diary and sleep related questions CE-approved non-medical device within intended use: Camera Non-medical device prototype: Bender, modified NightOwl video camera Other: PCs, Pole ( Monitor stand Generic, brand: König \& Meyer 26785-018-56, commercially available)
- Conditions
- Healty Babies, 3 Weeks - 3 Months Old
- Keywords
- Infants, physiology, behavior, respiration, sleep, unobtrusive monitoring, home setting
- Medical subject headings
- Behavior, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Can we measure baby behavior and physiology by camera and / or wearable?
Measured: through study completion, up to 1 year
Secondary outcomes (5)
Can we measure breathing at all by camera when the baby is in bed?
Measured: up to 3 months
Can we measure when the baby is in and out of bed?
Measured: up to 3 months
Can we derive sleep stages from the data?
Measured: up to 3 months
Can we detect and / or interpret baby crying?
Measured: up to 3 months
Can we distinguish the baby (audio & movement) from other people near the bed (i.e. parents and/or siblings)?
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start7 Feb 2022
- Primary completion6 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healty BabiesStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renee Otte, dr, Principal investigator, Philips Clinical & Medical Affairs Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175560
- Sponsor's protocol ID
- ICBE-S-000608
- Other IDs
- NL79600.100.21
- Status last verified
- Oct 2022
- First submitted
- 6 Dec 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data will be shared with Philips Mother and Child Care Business Unit : Questionnaires/diary, Activity data, Audio data, Video Data
Publications
Yue Sun, Wenjing Wang, Xi Long, Mohammed Meftah, Tao Tan, Caifeng Shan, Ronald M. Aarts, Peter H.N. de Widt; Respiration Monitoring for Premature Neonates in NICU; Appl. Sci. 2019, 9(23), 5246; https://doi.org/10.3390/app9235246
Lorato I, Stuijk S, Meftah M, Kommers D, Andriessen P, van Pul C, de Haan G. Towards Continuous Camera-Based Respiration Monitoring in Infants. Sensors (Basel). 2021 Mar 24;21(7):2268. doi: 10.3390/s21072268.
PubMed 33804913Khan AU, Mikut R, Reischl M. A Benchmark Data Set to Evaluate the Illumination Robustness of Image Processing Algorithms for Object Segmentation and Classification. PLoS One. 2015 Jul 20;10(7):e0131098. doi: 10.1371/journal.pone.0131098. eCollection 2015.
PubMed 26191792Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.
PubMed 15173539
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baby Breathing Monitoring @Home
- ClinicalTrials.gov ID
- NCT05175560
- Acronym / sponsor ID
- ICBE-S-000608
- Conditions
- Healty Babies, 3 Weeks - 3 Months Old
- Keywords
- Infants, physiology, behavior, respiration, sleep, unobtrusive monitoring, home setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 4 Jan 2022 (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.
To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology.
In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting.
The data collection will be divided in several sub-studies, either e.g. matching different development steps in the development of the algorithm or focusing on a specific baby population (e.g. specific age range). In general, babies will be monitored (audio, video, activity) for 24 -48 hours under their habitual sleeping conditions.
Step 1: 3 full data sets will be recorded of babies in bed aged 3 weeks to about 3-4 months, who are not able to turn over yet. Data will be analyzed and study set-up will be checked. Parents will be asked to keep a baby sleep diary and a questionnaire will be filled in at the start, with questions regarding the sleep behavior of their child. At the end, parents will be asked to fill in a questionnaire with sleep-related and feedback questions.
In step 2, 5 full data sets will be collected following the same procedure as step 1.
In step 3 12 full data sets will be collected following the same procedure as step 1.
After each step, the study setup including the algorithms, will be reviewed based on the obtained data. All modifications to this protocol will be submitted as amendments.
After step 1 and 2, the Mother and Child Care Business unit of Philips and other relevant stakeholders will be updated on the progress and findings by means of a (short) meeting and PowerPoint slides.
After step 3, a report will be written. The PowerPoint slides shared after Step 1 and 2 will be incorporated in this report.
Detailed description
Procedures Phone call
During the Phone call the investigators will:
- explain the study setup
- explain the exclusion and inclusion criteria. The criteria will not be verified until visit 1.
- if the parents or caregivers agree, an appointment will be made for visit 1
- Home visit 1 - about 45 min During the first home visit the investigators will: <!-- -->
- a. make introductions; <!-- -->
- b. explain the study again, if necessary, and answer questions; 1c. together with the subject's parents or caregivers sign the informed consent form belonging to this study;
- confirm the inclusion and exclusion criteria
- Complete the BISK questionnaire (investigator will ask questions to parent and report answers in CRF) 1d. Provide parents a baby sleep diary and instruct them to complete it; 1e. place the study setup in the room the baby mainly sleeps in; 1f. plan the second home visit. 2. During the study (2 consecutive days, including the nights) The setup will monitor the baby's bed, and the baby when the baby is in bed. After the setup is turned on, during Home Visit 1, it will record continuously for about two days (during day and night), until the investigator comes back to pick the setup up (see also Home Visit 2, below). The recording happens automatically; subject's parents or caregivers do not need to do anything with the setup.
The investigators will ask the parents or caregivers to keep a diary of the baby's (sleeping) behavior and to note information of behavior influencing the baby's sleep (e.g. baby being ill, not feeding well) during the recording period or if there was anything out of the ordinary with the setup (siblings fidgeting with it, power outings etc.).
In case of emergency, the recording can be stopped by pulling the electrical cord from the socket.
- Home visit 2 - ~30 min
During the second home visit, the investigators will:
3a. ask how the study went, and if the parents or caregivers have any feedback for the investigators (close out questionnaire, investigator will ask questions to parent and report answers in CRF); 3b. review the sleep diary for omissions 3c. Check the end time and study setup 3d. pick up the test setup.
After completion of the participation, the investigator will notify the recruitment agency to arrange the compensation.
Devices used:
Survey/questionnaire: Baby diary and sleep related questions CE-approved non-medical device within intended use: Camera Non-medical device prototype: Bender, modified NightOwl video camera Other: PCs, Pole ( Monitor stand Generic, brand: König \& Meyer 26785-018-56, commercially available)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 weeks to 4 months
- Sex
- All
- Age groups
- Child
- Study population
- healthy infants and their parents
Key inclusion criteria (5 listed)
- Have a baby aged >3 weeks to ~3-4 months (who is not yet able to role over; see exclusion criteria);
- Have a baby who sleeps in its own bed (i.e. different sleeping surface than parents; same room is allowed);
- Live in the Netherlands;.
- Are able to speak and read Dutch or English.
Key exclusion criteria (7 listed)
- Parents or caregivers
- with a baby who can already roll over (belly to back and back to belly);
- with a baby who is under supervision of an HCP because of health, feeding or developmental problems ;
- are unwilling or unable to provide informed consent on behalf of themselves, their baby and siblings;
- are unwilling or unable to comply with the study requirements;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can we measure baby behavior and physiology by camera and / or wearable?
Time frame: through study completion, up to 1 year
5 secondary outcomes
Can we measure breathing at all by camera when the baby is in bed?
Time frame: up to 3 months
Can we measure when the baby is in and out of bed?
Time frame: up to 3 months
Can we derive sleep stages from the data?
Time frame: up to 3 months
Can we detect and / or interpret baby crying?
Time frame: up to 3 months
Can we distinguish the baby (audio & movement) from other people near the bed (i.e. parents and/or siblings)?
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- BackgroundYue Sun, Wenjing Wang, Xi Long, Mohammed Meftah, Tao Tan, Caifeng Shan, Ronald M. Aarts, Peter H.N. de Widt; Respiration Monitoring for Premature Neonates in NICU; Appl. Sci. 2019, 9(23), 5246; https://doi.org/10.3390/app9235246
- Background: PubMed 33804913Lorato I, Stuijk S, Meftah M, Kommers D, Andriessen P, van Pul C, de Haan G. Towards Continuous Camera-Based Respiration Monitoring in Infants. Sensors (Basel). 2021 Mar 24;21(7):2268. doi: 10.3390/s21072268.
- Background: PubMed 26191792Khan AU, Mikut R, Reischl M. A Benchmark Data Set to Evaluate the Illumination Robustness of Image Processing Algorithms for Object Segmentation and Classification. PLoS One. 2015 Jul 20;10(7):e0131098. doi: 10.1371/journal.pone.0131098. eCollection 2015.
- Background: PubMed 15173539Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.
- Individual participant dataSharing planned: Yes. Coded data will be shared with Philips Mother and Child Care Business Unit : Questionnaires/diary, Activity data, Audio data, Video Data
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. This study is not recruiting at the moment.
Renee Otte, dr principal investigator
Philips Clinical & Medical Affairs Global
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 Healty Babies and 3 Weeks - 3 Months Old, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
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 7 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: finished, as of the sponsor's last update on 1 Nov 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Can we measure baby behavior and physiology by camera and / or wearable? (time frame: through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175560, which also lists 4 linked publications.
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 1 Nov 2022.