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Clinical Testing of a New Diagnostic Device

Clinical Validation of a Novel Compound Diagnostic Unit, NIBRA-CS for Assessment of Autonomic Neuro-Function Integrity - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087463
Enrollment
100
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: NIBRA CS: Test Device Non-Invasive Baro-Reflex Assessment Combined System (Duration - 30 mins) Control Intervention1: Control Device KODYSCAN: Commonly used device, KODYSCAN of Kody

Sponsors

Department of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy (asymptomatic) individuals of age between 16 and 65 years and of both gender residing in an urban community of Kolkata

Exclusion criteria

Exclusion criteria: Those who deemed physically unfit by the investigators to undergo autonomic function tests

Design outcomes

Primary

MeasureTime frame
Comparing two data sets using Bland-Altman PlotTimepoint: Single—

Secondary

MeasureTime frame
Time taken for completing the screeningTimepoint: Baseline;Ease of OperabilityTimepoint: Baseline—

Countries

India

Contacts

Public ContactShatavisa Mukherjee

School of Tropical Medicine

shatavisa100@gmail.com9830529192

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026