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

Aktiia

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT06356077

SHINE

Details and patient eligibility

About

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).

Enrollment: 1,729 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,729 participants in 1 patient group

Study cohort

Description:

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.