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A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the non-contact sensor at various distances from the subject. A total of 20 subjects were tested, from both genders, selected to represent a wide range of age and body mass index
The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue mercury thermometer.
The aim is to explore the variations in the human body that could have an effect on the radio reflection from the human torso, and thus affect the potential detection and accuracy of breathing rate. Factors that could affect non-contact RF performance are:
This was tested at a number of distances from the non-contact sensor and also with the subject having a thick comforter (duvet) laid across them.
The test conditions were
The use of the comforter in one test condition is to confirm that the RR measurement by the Reassure is unaffected by the thickness of clothing or blankets being worn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45 |
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| Measure | Description | Time Frame |
|---|---|---|
| Respiration Rate Accuracy | The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 8,800 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section | Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds |
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Inclusion Criteria:
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20 persons selected to cover the range of age and BMI of 18 to 45
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| Name | Affiliation | Role |
|---|---|---|
| Paul Phillips, MA, MSc | ResMed Sensor Technologies | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11863207 | Background | Lim WS, Carty SM, Macfarlane JT, Anthony RE, Christian J, Dakin KS, Dennis PM. Respiratory rate measurement in adults--how reliable is it? Respir Med. 2002 Jan;96(1):31-3. doi: 10.1053/rmed.2001.1203. |
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Trial is for device performance validation and only recorded with Clinical Trials.gov as it involved human volunteers. No intent to publish
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| ID | Title | Description |
|---|---|---|
| FG000 | Respiration Rate Sensor | All 20 subjects. Selected to have a range of ages (18 to 75) and BMI from 18.5 to 45. Actual: Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Respiration Rate Sensor | All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiration Rate Accuracy | The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 8,800 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section | Posted | Mean | Standard Deviation | breaths per minute | Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Respiration Rate Sensor | All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45. Actual: Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Phillips | ResMed | +447789633508 | paul.phillips@resmed.com |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45.
Actual:
Age 18 to 30 - quantity 12 31 to 49 - quantity 5 50 to 65 - quantity 3 BMI 18.5 to 24.9 (normal) - quantity 8 25 to 29.9 (overweight) - quantity 9 30 to 45 (obese) - quantity 3
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