A Study of Continuous Blood Pressure Monitoring in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Study to Investigate Continuous Blood Pressure Monitoring Using Traditional Device (ABPM) Versus Novel Devices (Biobeat and Aktiia)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Propranolol
* Drug: Pseudoephedrine
* Device: ABPM and Wearable Novel Devices
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABPM + Wearable Novel Devices + Propranolol<br>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. | Drug: Propranolol<br>* Administered orally.<br>Device: ABPM and Wearable Novel Devices<br>* ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.<br>|
| Experimental: ABPM + Wearable Novel Devices + Pseudoephedrine<br>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. | Drug: Pseudoephedrine<br>* Administered orally.<br>Device: ABPM and Wearable Novel Devices<br>* ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.<br>|
| Experimental: ABPM + Wearable Novel Devices Only<br>Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods. | Device: ABPM and Wearable Novel Devices<br>* ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.<br>Other: No Intervention<br>* No intervention during this period (Control Period)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change in Systolic Blood Pressure (SBP) Using Chest Patch Device | The Mean Change in SBP Using Chest Patch Device | Baseline through 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change in SBP Using Wrist Device | The Mean Change in SBP Using Wrist Device | Baseline through 48 hours | 
| The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device | The Mean Change in DBP Using Chest Patch Device and Wrist Device | Baseline through 48 hours | 
| The Mean Change in SBP Using Chest Patch Device and Wrist Device | The Mean Change in SBP Using Chest Patch Device and Wrist Device | Baseline through 120 hours | 
| The Mean Change in DBP Using Chest Patch Device and Wrist Device | The Mean Change in DBP Using Chest Patch Device and Wrist Device | Baseline through 120 hours | 
| The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM) | The Mean Change in SBP Using Chest Patch Device, Wrist Device and ABPM | Baseline through 48 hours | 
| The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM | The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM | Baseline through 48 hours |