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OpenTrials
Completed

NCT Number: NCT06356077

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

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).

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lindus Health

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Collaborators

  • Lindus Health

Registry information

Official study 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.

Acronym: SHINE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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