Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Sleep Clinical Trial

Official title:

Comparability of Bispectral Index and NeuroSENSE in Aged Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02015741
• Other study ID #: 2012/36
• Secondary ID: 2012-A01192-41
• Status: Withdrawn
• Phase: N/A
• First received: December 5, 2013
• Last updated: October 28, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• patients older than 74 years

Exclusion Criteria:

• pace-maker

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• EEG monitoring with Bispectral Index and NeuroSENSE

Behavioral:
• Clinical observation
Patients will be observed during awake periods and during natural sleep.

Locations

Country	Name	City	State
France	Hopital Stell	Rueil	Hauts de Seine
France	Hopital Foch	Suresnes	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices	Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices (high concordance when > 0.60%)	1 year	No
Secondary	Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep	Statistical analysis of concordance between pairs of Bispectral Index and NeuroSENSE indices measured during periods of natural sleep (high concordance when > 0.60%)	1 year	No