Trial Outcomes & Findings for Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen (NCT NCT02740504)

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 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

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds

Results posted on

2021-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Respiration Rate Sensor n=20 Participants All 20 subjects. Selected to have a range of ages (18 to less than 75) and BMI from 18.5 to 45
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Ireland	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds

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

Outcome measures

Outcome measures
Measure	Respiration Rate Sensor n=20 Participants 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
Respiration Rate Accuracy	0.4 breaths per minute Standard Deviation 1.75

Adverse Events

Respiration Rate Sensor

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: +447789633508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place