No Specific Medical Conditions or Disease StatesNCT06270953
Non-invasive Monitoring: Impact on Patient Management and Outcomes
An observational study of No Specific Medical Conditions or Disease States, run by Turtle Shell Technologies Pvt. Ltd. at 1 site in United States.
Trial summary
Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 months to 120 years
- Conditions the study is for
- No Specific Medical Conditions or Disease States
- What is being tested?
- Dozee Pro NX
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to 30 Jun 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 18 months to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted on subjects in the age group above 18 years regardless of gender. The study is done on patients admitted in the SNF who fulfill the inclusion and exclusion criteria
Who may be able to join
- Age 18 years or older.
- Weight between 40kg-120kgs
Who cannot join
- Terminal illness with a life expectancy of less than 1 month.
- Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
- Needs the use of equipment whose operation can interfere with Investigation System operations
- Patients planned to be transferred from the facility within 72 hours
- Prisoners
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-invasive Continuous Patient Monitoring System on Patient Management and Health Outcomes
Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.
Read the detailed description
In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.
- Being tested
- Dozee Pro NX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dozee Pro NXDevice
Dozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements
| Study group | Role | What they receive |
|---|---|---|
| Obervational group | Patients admitted in the SNF facility during the study period Receives: Device: Dozee Pro NX | |
| Control group | Historical control with patients admitted in the SNF before the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),
Measured: 3 months
Secondary outcomes (2)
HCP experience response data
Measured: 3 Months
Care pathway mapping
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start19 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific Medical Conditions or Disease StatesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Shell Technologies Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsay Darthard, LNFA, Principal investigator, Oak Village Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270953
- Sponsor's protocol ID
- DZ_NX_US
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 29 Sep 2025
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Continuous Patient Monitoring System on Patient Management and Health Outcomes
- ClinicalTrials.gov ID
- NCT06270953
- Acronym / sponsor ID
- DZ_NX_US
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Turtle Shell Technologies Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Feb 2024 (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.
Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.
Detailed description
In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obervational group | – | Device: Dozee Pro NXPatients admitted in the SNF facility during the study period |
| Control group | – | –Historical control with patients admitted in the SNF before the study period |
Who may qualify
- Ages
- 18 months to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted on subjects in the age group above 18 years regardless of gender. The study is done on patients admitted in the SNF who fulfill the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Weight between 40kg-120kgs
Key exclusion criteria (6 listed)
- Terminal illness with a life expectancy of less than 1 month.
- Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
- Needs the use of equipment whose operation can interfere with Investigation System operations
- Patients planned to be transferred from the facility within 72 hours
- Prisoners
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 |
|---|---|---|
| Dozee Pro NXDozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements | Device | Obervational group |
Primary outcome
Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),
Time frame: 3 months
2 secondary outcomes
HCP experience response data
Time frame: 3 Months
Care pathway mapping
Time frame: 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 29 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for No Specific Medical Conditions or Disease States
RecruitingObservational study
Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings
No Specific Medical Conditions or Disease States
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.
Lindsay Darthard, LNFA principal investigator
Oak Village Healthcare
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 No Specific Medical Conditions or Disease States, run by Turtle Shell Technologies Pvt. Ltd. at 1 site in United States.
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 2 inclusion and 6 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 29 Sep 2025. 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 States. 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?
Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions), (time frame: 3 months). 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 29 Sep 2025.