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

NCT ID: NCT06356077

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1729 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-04-30

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).

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lindus Health

INDUSTRY

Sponsor Role: collaborator

Aktiia SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lindus Health

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

SHINE

Identifier Type: -

Identifier Source: org_study_id