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

September 17, 2025 updated by: Aktiia SA

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1729

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure evolution over 12 weeks
Time Frame: 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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
3 months
Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aktiia SA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lindus Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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