Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate

Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04580615

Acronym

RRP

Enrollment

Registered

2020-10-08

Start date

2020-06-03

Completion date

2022-05-01

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease

Keywords

Respiratory rate

Brief summary

Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital

Detailed description

Hospitalized subjects, diagnosed with a Respiratory disease or subjects with no known Respiratory disease will be will be connected simultaneously to CardiacSense watch and Capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) by the CardiacSense watch. The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation. CardiacSense1 senses the radial artery inflation and deflation and together with a PPG sensors give an ultimate performance that is superior to PPG only.

Interventions

DEVICECardiacSense1 and capnograph Respiratory rate measurement

Inpatients Subjects with respiratory disease/impairment and Inpatients Subjects with no known respiratory disease/impairment will be measured simultaneously with both CardiacSense1 and capnograph for at least 30 minutes up to 24 hours. During this time capnograph data will be recorded in parallel to CardiacSense1.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age of eighteen (18) year and above * Diagnosed with Respiratory disease/impairment or without any known Respiratory disease/impairment * Ability and willingness to sign an informed consent form

Exclusion criteria

* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study * Patients with significant co morbidities (assessed by the clinician at screening only * BMI\>40 * Presence of an acute disease process that might interfere with test performance * Subjects with PPG SNR \<100 indicated by the CardiacSense1 device * Women who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
Respiratory rate	24 hours	Capnograph and Cardiacsense1 sensor Respiratory rate

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026