HypertensionSHINENCT06356077
SHINE: Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (SHINE)
An observational study of Hypertension, run by Aktiia SA at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertension
- How many people
- 1,729 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Participants whose BP data submitted is >180 mm Hg systolic OR >120 mm Hg diastolic .
- Participants with a self-reported known diagnosis of
- atrial fibrillation
- congestive heart failure
- heart valve disease
- pheochromocytoma
Show all 15Show fewer
- Raynaud's disease
- arm lymphedema
- 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
- Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure evolution over 12 weeks
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.
Measured: 3 months
Secondary outcomes (2)
Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor
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.
Measured: 3 months
Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.
Statistics on a potential correlation between Blood Pressure measurements and subjects responses to questionnaires regarding their lifestyle, socioeconomic environment and general health.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start31 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356077
- Sponsor's protocol ID
- SHINE
- Acronym
- SHINE
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06356077
- Acronym / sponsor ID
- SHINE / SHINE
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,729 participants (actual)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Adult participants aged 22 to 85 years old
- A participant whose last blood pressure reading was within the last 12 months and was either:
- 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.
Key exclusion criteria (15 listed)
- Participants whose BP data submitted is >180 mm Hg systolic OR >120 mm Hg diastolic .
- Participants with a self-reported known diagnosis of
- Participants who take insulin
- Participants who are on hemodialysis
- Women who are self-reported to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Aktiia SA at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure evolution over 12 weeks (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.