Trial Outcomes & Findings for Reassure Device: Measurement Accuracy of Continuous Respiration Rate (NCT NCT02740478)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

2 hour recording

Results posted on

2021-04-02

Participant Flow

Volunteer subjects recruited until quantity 20 had completed the study

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Reassure Device: Measurement Accuracy of Continuous Respiration Rate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reassure 10.5 GHz Sensor Sleep Simulation n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Region of Enrollment Ireland	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Reassure 10.5 GHz Sensor Sleep Simulation n=20 Participants 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.
Respiration Rate Comparability	0.4 breaths per minute Standard Deviation 1.2

Adverse Events

Reassure 10.5 GHz Sensor Sleep Simulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Phillips

ResMed

Phone: +44 7789633508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place