A Study of Continuous Blood Pressure Monitoring in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05692869
• Other study ID #: 18655
• Secondary ID: H6O-MC-O017
• Status: Completed
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Propranolol
Administered orally.
• Pseudoephedrine
Administered orally.

Device:
• ABPM and Wearable Novel Devices
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.

Other:
• No Intervention
No intervention during this period (Control Period)

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Mean Change in SBP Using Wrist Device	The Mean Change in SBP Using Wrist Device	Baseline through 48 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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