SHINE: Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (SHINE) (SHINE)

SHINE Study: Blood Pressure Evolution and User Satisfaction in a Hypertensive Population Using the Aktiia 24/7 Optical Blood Pressure Monitoring (OBPM) Device: a Prospective Observational Cohort Study.

The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).

Study Overview

• Status: Completed
• Conditions: Hypertension

• Study Type: Observational
• Enrollment (Actual): 1729

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Lindus Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The final study population should cover the following phenotypes:

• Close to 50% females and 50% males,
• At least 20% of non-Caucasian participants,
• At least 20% of participants with Systolic Blood Pressure (SBP) ≥150mmHg (assessed at baseline via the study device).

Description

Inclusion Criteria:

1. Adult participants aged 22 to 85 years old

2. A participant whose last blood pressure reading was within the last 12 months and was either:

   1. SBP ≥145
   2. or ≥DBP 90
3. People who use either an iOS or Android smartphone
4. People who have 2 arms
5. Able and willing to provide informed consent and to adhere to study procedures.

Exclusion Criteria:

1. Participants whose BP data submitted is >180 mm Hg systolic OR >120 mm Hg diastolic .

2. Participants with a self-reported known diagnosis of

   1. atrial fibrillation
   2. congestive heart failure
   3. heart valve disease
   4. pheochromocytoma
   5. Raynaud's disease
   6. arm lymphedema
3. Participants who take insulin
4. Participants who are on hemodialysis
5. Women who are self-reported to be pregnant
6. Participants whose arms shake uncontrollably or are paralyzed (cannot move)
7. Participants with upper arm circumference <22 cm or >42 cm
8. Participants with wrist circumference >23cm
9. Participation in another interventional clinical study or use of investigational drugs in the last 30 days.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study cohort; Each study subject will receive an Aktiia device and will use it continuously for 3 months. Study participants will have to complete 2 different surveys: one at baseline, and one after the 3 months of Aktiia device use to give their perception on the Aktiia device use as compared to other blood pressure monitors currently on the market.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure evolution over 12 weeks	Means, medians, standard deviations, and ranges for Blood Pressure readings and changes in Blood Pressure readings within the study population between week 1 to week 12.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor	Number of participants with preferences using Aktiia 24/7 device, as copared to Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor to monitor their blood pressure.	3 months
Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.	Statistics on a potential correlation between Blood Pressure measurements and subjects responses to questionnaires regarding their lifestyle, socioeconomic environment and general health.	3 months

Collaborators and Investigators

• Sponsor: Aktiia SA
• Collaborators: Lindus Health

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: SHINE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No