Cardiovascular DiseasesVISION-JrNCT05850013
The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care
An observational study of Cardiovascular Diseases and Respiratory Disease, run by Xim Limited at 1 site in United Kingdom.
Trial summary
A prospective basic science study for collection of training and testing data for development of Lifelight® Junior Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiovascular Diseases, Respiratory Disease, Febrile Illness
- What is being tested?
- Lifelight Junior
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 504 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 1 Apr 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We will be recruiting 500 child participants in the paediatric emergency department (PED) and hospital wards. The number will also include particiapnts for sub-protocols to measure blood pressure and record an electrocardiogram (ECG) in compliant and eligible participants and to conduct post-measurement questionnaires. A pilot project involving up to 10% (50) participants will run for 3 weeks in advance of the study with the aim of identifying the most efficient and effective way to deliver the study activities.
Who may be able to join
- Children (0-18 years old) attending the paediatric ED or who are inpatients on the paediatric wards at STSFT
Who cannot join
- Critically ill children (judged so by treating physicians), including unconscious children
- Children who are non-compliant in terms of excessive movement during the measurement
- Children of parents/guardians/carers who are non-English speakers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
About this study
Official title: The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
A prospective basic science study for collection of training and testing data for development of Lifelight® Junior
Read the detailed description
This study will be hospital-based, including paediatric emergency department (PED), inpatient wards and outpatient departments).
The participants will have their vital signs (such as heart rate, respiratory rate, oxygen saturation, blood pressure and temperature) measured using standard-of-care methods. Concurrent with this, videos of the participants' face/torso, and audio of the sounds made by the participants (cry, wheeze, cough) will be recorded. These data will later be used to train the Lifelight® Junior algorithms so that the technology can help in detection of illness and deterioration in children.
Primary Objective Collect the data needed to develop Lifelight® Junior so that it can measure the heart rate, respiratory rate and oxygen saturation of children.
Secondary Objective
- Assess the feasibility of developing other (direct or indirect) measurement functions in Lifelight® Junior, including temperature, blood pressure, heart rate variability and audio analysis (cry, wheeze, cough).
- Evaluate the impact of subject-specific variables on the vital sign measurements e.g., medication, cosmetics, facial/body hair and skin tone.
- Obtain data to understand patient and parent/guardian/carer vital sign measurement habits and preferences
- Assess the usability of Lifelight® Junior for measuring vital signs in children
To ensure the study collects data that can train Lifelight® Junior in an efficient way, the recruitment should be divided as follows:
- At least 12% of study participants should fall into each of the following age bands:
- Age 0-1
- Age 1-2
- Age 2-5
- Age 5-11
- Age 11-14
- Age 14-18
- At least 40% of the study participants shall be male and at least 40% shall be female.
- At least 40% of the study participants shall be each of the following:
- Febrile (≥ 38°C) measured how?
- Afebrile
- Ill (as judged by the clinical staff), of whom at most 50% shall have an acute respiratory illness e.g., bronchiolitis, asthma, viral induced wheeze, pneumonia, croup, etc.
- Well, including children with a minor injury
Ideally, 15% of participants should have a Fitzpatrick skin tone of 4, 5 or 6 First reference to this - need to bring it in earlier and to reference it. However, this is not a hard target as achieving this figure is dependent on the demographic diversity of the study region.
- Being tested
- Lifelight Junior
- Keywords
- video, audio, vital signs
- Medical subject headings
- Cardiovascular Diseases, Respiration Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifelight JuniorDevice
Lifelight® is an app developed by xim that measures VS including heart rate, respiratory rate and blood pressure. All you need to do to have these vital signs measured is look at your smartphone or tablet camera for 20-40 seconds. The app has used data from over 1 million heartbeats to learn how to measure these vital signs in adults. The technology is already available for doctors and nurses to use with adult patients in some specific scenarios
| Study group | Role | What they receive |
|---|---|---|
| Sub Protocol 1 | Sub protocol 1 - Blood pressure measured in participants who are able to cooperate and are relatively still Within each study session, compliant participants will have their blood pressure measured using standard-of-care equipment and methods during the same 60 seconds that their other vital signs are measured Receives: Device: Lifelight Junior | |
| Sub protocol 2 | OPTIONAL Sub protocol 2: Electrocardiogram (ECG) for measurement of Heart rate variability This sub-protocol is relevant for children who would benefit from having a 3-lead ECG to capture beat to beat variability. This will be done in a subset of the participants, and ideally on a subsequent that is representative of the full cohort of participants in terms of age profile, skin tone distribution and illness. Receives: Device: Lifelight Junior | |
| Sub protocol 3 | The questionnaire will ask questions related to vital sign monitoring habits and preferences, or not, of Lifelight®-type technologies for measuring vital signs instead of standard-of-care methods. Receives: Device: Lifelight Junior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall outcome measure
Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
Measured: 6 months
Heart rate
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets:
- Heart rate
- Root mean square error of 5 bpm or lower
Measured: 6 months
Respiratory rate
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets:
- Respiratory rate
- Maximum error of 5 breaths per minute for 100% of the measurements
Measured: 6 months
Oxygen saturation level (percentage)
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets:
- Oxygen saturation
- Maximum error tolerance of 4%.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 May 2023
- Primary completion31 Aug 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prospective
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Tyneside and Sunderland NHS Foundation Trust, Mind Over Matter Medtech Ltd
- Responsible party
- Sponsor
- Investigators
- Niall Mullen, MB BCh, Principal investigator, South Tyneside and Sunderland Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850013
- Sponsor's protocol ID
- IRAS Reference: 321956
- Acronym
- VISION-Jr
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misra G, Wegerif S, Fairlie L, Kapoor M, Fok J, Salt G, Halbert J, Maconochie I, Mullen N. The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR Res Protoc. 2025 Mar 14;14:e58334. doi: 10.2196/58334.
PubMed 40085833
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Vital Signs in Children by Lifelight® Software in Comparison to the Standard of Care The VISION-Junior Study
- ClinicalTrials.gov ID
- NCT05850013
- Acronym / sponsor ID
- VISION-Jr / IRAS Reference: 321956
- Keywords
- video, audio, vital signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Collaborators
- South Tyneside and Sunderland NHS Foundation Trust, Mind Over Matter Medtech Ltd
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 9 May 2023 (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.
A prospective basic science study for collection of training and testing data for development of Lifelight® Junior
Detailed description
This study will be hospital-based, including paediatric emergency department (PED), inpatient wards and outpatient departments).
The participants will have their vital signs (such as heart rate, respiratory rate, oxygen saturation, blood pressure and temperature) measured using standard-of-care methods. Concurrent with this, videos of the participants' face/torso, and audio of the sounds made by the participants (cry, wheeze, cough) will be recorded. These data will later be used to train the Lifelight® Junior algorithms so that the technology can help in detection of illness and deterioration in children.
Primary Objective Collect the data needed to develop Lifelight® Junior so that it can measure the heart rate, respiratory rate and oxygen saturation of children.
Secondary Objective
- Assess the feasibility of developing other (direct or indirect) measurement functions in Lifelight® Junior, including temperature, blood pressure, heart rate variability and audio analysis (cry, wheeze, cough).
- Evaluate the impact of subject-specific variables on the vital sign measurements e.g., medication, cosmetics, facial/body hair and skin tone.
- Obtain data to understand patient and parent/guardian/carer vital sign measurement habits and preferences
- Assess the usability of Lifelight® Junior for measuring vital signs in children
To ensure the study collects data that can train Lifelight® Junior in an efficient way, the recruitment should be divided as follows:
- At least 12% of study participants should fall into each of the following age bands:
- Age 0-1
- Age 1-2
- Age 2-5
- Age 5-11
- Age 11-14
- Age 14-18
- At least 40% of the study participants shall be male and at least 40% shall be female.
- At least 40% of the study participants shall be each of the following:
- Febrile (≥ 38°C) measured how?
- Afebrile
- Ill (as judged by the clinical staff), of whom at most 50% shall have an acute respiratory illness e.g., bronchiolitis, asthma, viral induced wheeze, pneumonia, croup, etc.
- Well, including children with a minor injury
Ideally, 15% of participants should have a Fitzpatrick skin tone of 4, 5 or 6 First reference to this - need to bring it in earlier and to reference it. However, this is not a hard target as achieving this figure is dependent on the demographic diversity of the study region.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub Protocol 1 | – | Device: Lifelight JuniorSub protocol 1 - Blood pressure measured in participants who are able to cooperate and are relatively still Within each study session, compliant participants will have their blood pressure measured using standard-of-care equipment and methods during the same 60 seconds that their other vital signs are measured |
| Sub protocol 2 | – | Device: Lifelight JuniorOPTIONAL Sub protocol 2: Electrocardiogram (ECG) for measurement of Heart rate variability This sub-protocol is relevant for children who would benefit from having a 3-lead ECG to capture beat to beat variability. This will be done in a subset of the participants, and ideally on a subsequent that is representative of the full cohort of participants in terms of age profile, skin tone distribution and illness. |
| Sub protocol 3 | – | Device: Lifelight JuniorThe questionnaire will ask questions related to vital sign monitoring habits and preferences, or not, of Lifelight®-type technologies for measuring vital signs instead of standard-of-care methods. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We will be recruiting 500 child participants in the paediatric emergency department (PED) and hospital wards. The number will also include particiapnts for sub-protocols to measure blood pressure and record an electrocardiogram (ECG) in compliant and eligible participants and to conduct post-measurement questionnaires. A pilot project involving up to 10% (50) participants will run for 3 weeks in advance of the study with the aim of identifying the most efficient and effective way to deliver the study activities.
Key inclusion criteria (1 listed)
- Children (0-18 years old) attending the paediatric ED or who are inpatients on the paediatric wards at STSFT
Key exclusion criteria (3 listed)
- Critically ill children (judged so by treating physicians), including unconscious children
- Children who are non-compliant in terms of excessive movement during the measurement
- Children of parents/guardians/carers who are non-English speakers
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 |
|---|---|---|
| Lifelight JuniorLifelight® is an app developed by xim that measures VS including heart rate, respiratory rate and blood pressure. All you need to do to have these vital signs measured is look at your smartphone or tablet camera for 20-40 seconds. The app has used data from over 1 million heartbeats to learn how to measure these vital signs in adults. The technology is already available for doctors and nurses to use with adult patients in some specific scenarios | Device | Sub Protocol 1, Sub protocol 2, Sub protocol 3 |
Primary outcome
Overall outcome measure
Time frame: 6 months
Train Lifelight algorithms across more extensive paediatric clinical ranges in 500 subjects
Heart rate
Time frame: 6 months
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Heart rate o Root mean square error of 5 bpm or lower
Respiratory rate
Time frame: 6 months
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Respiratory rate o Maximum error of 5 breaths per minute for 100% of the measurements
Oxygen saturation level (percentage)
Time frame: 6 months
The following accuracy metrics are indicative minimum performance requirements for Lifelight® Junior. VISION-Junior should progress the technology towards these performance targets: • Oxygen saturation o Maximum error tolerance of 4%.
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 18 Jul 2024.
- Derived from this study: PubMed 40085833Misra G, Wegerif S, Fairlie L, Kapoor M, Fok J, Salt G, Halbert J, Maconochie I, Mullen N. The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR Res Protoc. 2025 Mar 14;14:e58334. doi: 10.2196/58334.
- 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. This study is not recruiting at the moment.
Niall Mullen, MB BCh principal investigator
South Tyneside and Sunderland Foundation Trust
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 Cardiovascular Diseases and Respiratory Disease, run by Xim Limited at 1 site in United Kingdom.
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 1 inclusion and 3 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 18 Jul 2024. 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 United Kingdom. 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?
Overall outcome measure (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05850013, which also lists 1 linked publication.
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 18 Jul 2024.