Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02740478 |
| Other study ID # |
D22105-107 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
July 2015 |
Study information
| Verified date |
March 2021 |
| Source |
ResMed |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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
