Clinical trial NCT02740504: Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
Official title: A Test of the Spot Respiration Rate Accuracy of the New Reassure Device on Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Measurement of Respiration Rate
Keywords: Respiration rate
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 persons selected to cover the range of age and BMI of 18 to 45

Brief summary: 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

Detailed description: 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:

* High Body Mass Index (BMI) could potentially reduce the chest wall movement during breathing, or alter the nature of the breathing.
* Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.
* Female breast tissue may have an effect on detection or accuracy.

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

* Distances of 0.5 m, 1.0m and 1.5m between the subject and the RF sensor.
* Additional test condition of comforter (duvet) on the subject when the distance from subject to sensor is 1.0 m.
* Each test condition carried out twice.

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.

Eligibility criteria: Inclusion Criteria:

* Greater or equal to 18 years old and less than or equal to 75 years old
* BMI within the range of greater or equal to 18 and less than or equal to 45

Primary outcomes:
measure: Respiration Rate Accuracy
timeFrame: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ResMed Sensor Technologies
name: Paul Phillips, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.