Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals (HELD)

Mode Sensors

Status: Enrolling

Conditions: Dehydration

Treatments: Device: Wearable bioimpedance sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05831800

CTR0061A HELD

Details and patient eligibility

About

This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years

Exclusion criteria

• Known allergies or skin sensitivities to electrode hydrogel and/or acrylic-based adhesives
• Non-intact skin such as skin breakdown where the device is to be placed (upper back)
• Implantable pulse generators such as pacemakers and defibrillators
• Any medical or psychiatric condition, which in the opinion of the investigator precludes participation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Wearable bioimpedance sensor

Other group

Treatment:

Device: Wearable bioimpedance sensor