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

Completed

• Conditions: Hypertension

• Registration Number: NCT06356077
• Lead Sponsor: Aktiia SA

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-10
• Study Start: 2024-07-31
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1729

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Pressure evolution over 12 weeks	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lindus Health; 🇬🇧 London, United Kingdom