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The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep
Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.
The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.
Key Duration Remarks Supine >=20minutes Subject Lying on back Prone >=20minutes Subject Lying face down Facing Left >=20minutes Subject's Chest facing Reassure device Facing Right >=20minutes Subject's Back facing Reassure device Foetal Left >=20minutes Subject's Chest facing Reassure device Foetal Right >=20minutes Subject's Back facing Reassure device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers | 20 volunteer subjects, no selection criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| Respiration Rate Comparability | The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the whole recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings are plotted on a normal distribution chart, giving 130,000 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 | 2 hour recording |
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Inclusion Criteria:
Exclusion Criteria:
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Quantity 20 volunteer subjects willing to undergo the trial: lying still for 2 hours, following a pre-scripted set on lying positions.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Phillips, MA, MSc | ResMed Sensor Technologies Ltd | 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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Device performance validation, only registered with Clinicaltrials.gov as it entailed human volunteers. No intent to publish
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Volunteer subjects recruited until quantity 20 had completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Reassure 10.5 GHz Sensor Sleep Simulation | Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate. Volunteers recruited until there were 20 that completed the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reassure 10.5 GHz Sensor Sleep Simulation | Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate. Volunteers recruited until there were 20 that completed the study. |
| Units | Counts |
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| 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 Comparability | The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the whole recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings are plotted on a normal distribution chart, giving 130,000 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 | 2 hour recording |
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2 hours during which the evaluation took place
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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 | Reassure 10.5 GHz Sensor Sleep Simulation | Volunteer subjects, willing to undergo the trial of lying still on a bed for 2 hours. The subject's position changed every 20 minutes so that a range of positions explored. Subjects' respiration rate measure by the non-contact Reassure device and compared to a SomnoScreen device that uses chest effort belts to record the respiration rate. Volunteers recruited until there were 20 that completed the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Phillips | ResMed | +44 7789633508 | 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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| 0 |
| 21 |
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| 21 |
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| 21 |
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