Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02740504
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
Sponsor:
ResMed
Organization:
Study Overview
Official Title:
A Test of the Spot Respiration Rate Accuracy of the New Reassure Device on Human Subjects
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: