Skip to content

Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02015741
Enrollment
0
Registered
2013-12-19
Start date
2013-11-30
Completion date
2015-12-31
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Brief summary

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

Interventions

DEVICEEEG monitoring with Bispectral Index and NeuroSENSE
BEHAVIORALClinical observation

Patients will be observed during awake periods and during natural sleep.

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients older than 74 years

Exclusion criteria

* pace-maker

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices1 yearStatistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when \> 0.60%)

Secondary

MeasureTime frameDescription
Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep1 yearStatistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when \> 0.60%)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026