A Study of Continuous Blood Pressure Monitoring in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-04-04

Brief Summary

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The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABPM + Wearable Novel Devices + Propranolol

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with propranolol administered orally for 5 days in one of three study periods.

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Administered orally.

ABPM and Wearable Novel Devices

Intervention Type DEVICE

ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

ABPM + Wearable Novel Devices + Pseudoephedrine

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with pseudoephedrine administered orally for 5 days in one of three study periods.

Group Type EXPERIMENTAL

Pseudoephedrine

Intervention Type DRUG

Administered orally.

ABPM and Wearable Novel Devices

Intervention Type DEVICE

ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

ABPM + Wearable Novel Devices Only

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.

Group Type EXPERIMENTAL

ABPM and Wearable Novel Devices

Intervention Type DEVICE

ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

No Intervention

Intervention Type OTHER

No intervention during this period (Control Period)

Interventions

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Propranolol

Administered orally.

Intervention Type DRUG

Pseudoephedrine

Administered orally.

Intervention Type DRUG

ABPM and Wearable Novel Devices

ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

Intervention Type DEVICE

No Intervention

No intervention during this period (Control Period)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy males or females
* Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have history of sensitive skin or chronic skin conditions, like eczema
* Regular use of known drugs of abuse
* Are women who are pregnant or lactating
* Have known allergies to medications used in the study

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes