Accuracy of Respiration Rate Measurement
Conditions
Brief summary
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
Detailed description
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
Interventions
None listed
Sponsors
ResMed
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing Volunteer
Exclusion criteria
* Restless leg syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiration Rate Comparability | 2 hour recording | 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 |
Participant flow
Recruitment details
Volunteer subjects recruited until quantity 20 had completed the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Reassure 10.5 GHz Sensor Sleep Simulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Region of Enrollment Ireland | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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
Time frame: 2 hour recording
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reassure 10.5 GHz Sensor Sleep Simulation | Respiration Rate Comparability | 0.4 breaths per minute | Standard Deviation 1.2 |