Monitoring, PhysiologicLYNG21NCT05117606
LYNG21: Ably LYNG Clinical Demonstration in Operative Environment
A study testing LYNG by Ably Medical in people with Monitoring, Physiologic, run by Ably Medical AS at 1 site in Norway.
Trial summary
The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monitoring, Physiologic
- What is being tested?
- LYNG by Ably Medical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 25 May 2021to 31 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients:
- Admitted to hospital,
- Able to provide voluntary, informed consent.
Who cannot join
- For patients:
- Health condition that endangers patient by participation due to pain, rehabilitation, and/or negative impact on treatment or care, as evaluated by medical personnel,
- Pregnancy,
- Significantly reduced mobility that implies substantial strain for moving in and out of bed, as evaluated by medical personnel
- Unable to provide informed, voluntary consent personally or by legal guardian, * below 18 years old,
- Patients with implantable devices such as pacemakers, baclofen pumps, insulin pumps, etc, or
- Any way identified as 'vulnerable'
- The nurse handing recruitment will explicitly check for inclusion/exclusion criteria alignment and document this in the study Enrolment Form. The routine will be to check for formal criteria and to describe the study in such a manner that the patient understands content, and make sure the patient understands before consenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.
The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. The comparison will show the degree of agreement between LYNG and the existing current standard equipment. Data from the study will support Ably Medical in optimizing the LYNG product and measurement precision.
Read the detailed description
The LYNG sensor mat is placed beneath a regular bed matrass and captures data without direct patient contact. Data collected by the LYNG sensor is transmitted via cables to the bed-side connectivity box for initial local analysis and storage. Data will be extracted and formatted for post-analysis in additional software for verification and validation purposes.
Specifically, the LYNG study objectives are as follows:
- collect sensor data from LYNG Solution to optimize the LYNG data algorithms to further improve parameter estimations of patient heart rate, respiratory rate, blood pressure and movement indicators.
- Compare parameter estimation by LYNG against current and relevant standard of care measurement methods
The study design is a within-subjects comparison in parameter estimation with Ably LYNG as comparator to standard of care. Patients will take part in 60-minute sessions where measurements are collected in accidence to standard procedure for the standard equipment while the LYNG system collects the same data non- intrusively. The data will not be part of any clinical decision making or have any impact of the patient care. The study will take place during Q2-Q3/2021 with estimated 8-12 weeks duration including logistics, setup, data collection, study closure.
- Conditions
- Monitoring, Physiologic
- Being tested
- LYNG by Ably Medical
- Keywords
- non-intrusive monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYNG by Ably MedicalDevice
Comparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Vitalsigns | Other | Data from patients (heart rate, respiration, movement, blood pressure) is measured with traditional, standard hospital equipment in parallell with data from LYNG mat captured non-intrusively in the same session. Receives: Device: LYNG by Ably Medical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Relative Error of Heart Rate (beats per minute)
absolute relative error = (reference measure/LYNG measure)/Reference
Measured: 60 minutes
Absolute Relative Error of Respiration Rate (respirations per minute)
absolute relative error = (reference measure/LYNG measure)/Reference
Measured: 60 minutes
Movement
Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis.
Measured: 60 minutes
absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference
absolute relative error = (reference measure/LYNG measure)/Reference
Sphygmomanometer, millimeters of mercury (mmHg) upper (systolic), lower (diastolic), and mean value.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start25 May 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring, PhysiologicStudies 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
- Model description
- Within subject comparison - of two screening methodologies (standard equipment with direct patient sensors vs LYNG contactless sensors). The number patients in the study is chosen to have a broad view on patients population found in a general hospital setting, for example a range of height, weight, gender, age.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ably Medical AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Dag A Lihaug Hoff, Principal investigator, HMR Aalesund Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117606
- Sponsor's protocol ID
- LYNG21_AALESUND
- Acronym
- LYNG21
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLY LYNG Study at Helse More Romsdal - Aalesund Sykehus HMR With the Ably LYNG Patient Care Solution Advanced Prototype by Ably Medical AS.
- ClinicalTrials.gov ID
- NCT05117606
- Acronym / sponsor ID
- LYNG21 / LYNG21_AALESUND
- Conditions
- Monitoring, Physiologic
- Keywords
- non-intrusive monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ably Medical ASIndustry (pharma, biotech, devices)
- Collaborators
- Alesund Hospital
- Study start
- 25 May 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Nov 2021 (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.
The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. The comparison will show the degree of agreement between LYNG and the existing current standard equipment. Data from the study will support Ably Medical in optimizing the LYNG product and measurement precision.
Detailed description
The LYNG sensor mat is placed beneath a regular bed matrass and captures data without direct patient contact. Data collected by the LYNG sensor is transmitted via cables to the bed-side connectivity box for initial local analysis and storage. Data will be extracted and formatted for post-analysis in additional software for verification and validation purposes.
Specifically, the LYNG study objectives are as follows:
- collect sensor data from LYNG Solution to optimize the LYNG data algorithms to further improve parameter estimations of patient heart rate, respiratory rate, blood pressure and movement indicators.
- Compare parameter estimation by LYNG against current and relevant standard of care measurement methods
The study design is a within-subjects comparison in parameter estimation with Ably LYNG as comparator to standard of care. Patients will take part in 60-minute sessions where measurements are collected in accidence to standard procedure for the standard equipment while the LYNG system collects the same data non- intrusively. The data will not be part of any clinical decision making or have any impact of the patient care. The study will take place during Q2-Q3/2021 with estimated 8-12 weeks duration including logistics, setup, data collection, study closure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject comparison - of two screening methodologies (standard equipment with direct patient sensors vs LYNG contactless sensors). The number patients in the study is chosen to have a broad view on patients population found in a general hospital setting, for example a range of height, weight, gender, age.
| Arm | Type | Receives |
|---|---|---|
| Vitalsigns | Other | Device: LYNG by Ably MedicalData from patients (heart rate, respiration, movement, blood pressure) is measured with traditional, standard hospital equipment in parallell with data from LYNG mat captured non-intrusively in the same session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For patients:
Key exclusion criteria (8 listed)
- For patients:
- The nurse handing recruitment will explicitly check for inclusion/exclusion criteria alignment and document this in the study Enrolment Form. The routine will be to check for formal criteria and to describe the study in such a manner that the patient understands content, and make sure the patient understands before consenting
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 |
|---|---|---|
| LYNG by Ably MedicalComparing LYNG to traditional, standard equipment for heart rate, respiration, movement, and blood pressure. | Device | Vitalsigns |
Primary outcome
Absolute Relative Error of Heart Rate (beats per minute)
Time frame: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference
Absolute Relative Error of Respiration Rate (respirations per minute)
Time frame: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference
Movement
Time frame: 60 minutes
Comparison of movement as part of patient instruction compared to indications of movement in movement sensors. Qualitative analysis.
absolute relative error of Blood Pressure = (reference measure/LYNG measure)/Reference
Time frame: 60 minutes
absolute relative error = (reference measure/LYNG measure)/Reference Sphygmomanometer, millimeters of mercury (mmHg) upper (systolic), lower (diastolic), and mean value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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.
Dag A Lihaug Hoff principal investigator
HMR Aalesund Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LYNG by Ably Medical in people with Monitoring, Physiologic, run by Ably Medical AS at 1 site in Norway.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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 Norway. 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?
Results are not available in the source record.
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?
Absolute Relative Error of Heart Rate (beats per minute) (time frame: 60 minutes). 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?
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 11 Nov 2021.