NCT06356077Completed
SHINE: Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (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.
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1729 (actual)
- First submitted
- 20 Mar 2024
- Start date
- 31 Jul 2024
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Aktiia SA
- Diseases
- High blood pressure
- NCT number
- NCT06356077
What you commit to
- Study type: Observational
- Participants enrolled: 1729
- From 31 Jul 2024 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
Other illness
- Participants with a self-reported known diagnosis of
- atrial fibrillation
- congestive heart failure
- heart valve disease
- pheochromocytoma
- Raynaud's disease
- arm lymphedema
Other
- Participants whose BP data submitted is \>180 mm Hg systolic OR \>120 mm Hg diastolic .
- Participants who take insulin
- Participants who are on hemodialysis
- Women who are self-reported to be pregnant
- Participants whose arms shake uncontrollably or are paralyzed (cannot move)
- Participants with upper arm circumference \<22 cm or \>42 cm
- Participants with wrist circumference \>23cm
Who the study is looking for
- Adult participants aged 22 to 85 years old
- A participant whose last blood pressure reading was within the last 12 months and was either:
- SBP ≥145
- or ≥DBP 90
- People who use either an iOS or Android smartphone
- People who have 2 arms
- Able and willing to provide informed consent and to adhere to study procedures.
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lindus Health Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.