N/A
Completed N=48
Usability Evaluation - Reassure Respiration Rate Device: Home User Study
Ease of Use
Source: ClinicalTrials.gov NCT02740517 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Percentage of Nights' Data That Were Successfully Recorded — 79; 86; 100 percentage of nights' data
Summary
This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.
The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Nights' Data That Were Successfully Recorded |
79; 86; 100 | — |
| SECONDARY Percentage of Recordings With Successful First Time Transmission |
49; 76.7; 96.7 | — |
Eligibility Criteria
Inclusion Criteria
- volunteer, no previous exposure to the device
Exclusion Criteria
- restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
Data sourced from ClinicalTrials.gov (NCT02740517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.