Reassure Device: Measurement Accuracy of Continuous Respiration Rate

NCT ID: NCT02740478

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

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

Conditions

Accuracy of Respiration Rate Measurement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Volunteers

20 volunteer subjects, no selection criteria

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Willing Volunteer

Exclusion Criteria

• Restless leg syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Phillips, MA, MSc

Role: PRINCIPAL_INVESTIGATOR

ResMed Sensor Technologies Ltd

References

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.

Reference Type: BACKGROUND

PMID: 11863207 (View on PubMed)

Other Identifiers

D22105-107

Identifier Type: -

Identifier Source: org_study_id