Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices

Not Applicable

Not yet recruiting

• Conditions: Blood Pressure

• Registration Number: NCT06573801
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Participant is aged =21 years and <85 years at the time of screening visit.<br><br> 2. Able to speak and understand English.<br><br> 3. Able and willing to give informed consent.<br><br> 4. Independent and mobile.<br><br> 5. Willing and able to wear devices/no upper limb restrictions.<br><br>Exclusion Criteria:<br><br> 1. Individuals who are or have been involved in interventional research within a period<br> of 3 months.<br><br> 2. Vulnerable individuals including those with mental ill-health or who are care<br> dependant.<br><br> 3. Individuals with serious comorbidities or end organ damage (e.g., previously<br> diagnosed heart failure with New York Heart Association class III/IV, verbal or<br> documented evidence of renal failure stage 3 or worse or history of dialysis, stroke<br> or myocardial infarction within the last 1-year, previous stroke with residual<br> deficit); and doctor diagnosed hyperthyroidism.<br><br> 4. Individuals with arterio-venous fistula; or reduced peripheral perfusion identified<br> by a history of Raynaud's syndrome or a pulse pressure of <30mmHg or a capillary<br> refill time of >3s in the dominant arm.<br><br> 5. Individuals with heart rhythm disorders e.g., atrial fibrillation.<br><br> 6. Individuals with skin irritation injury or damage.<br><br> 7. Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy<br> following enrolment.<br><br> 8. Life threatening or terminal illness with limited lifespan.<br><br> 9. Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the<br> range highlighted in each device's specification.<br><br> 10. Those with very high office BP (greater than Stage 3 hypertension).<br><br> 11. Interarm difference >15mmHg in Systolic BP and >10mmHg in Diastolic BP.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Daytime BP Difference

Secondary Outcome Measures

Name	Time	Method
Mean 24 hours BP Difference;Mean Nighttime BP Difference;Difference in Blood Pressure Variability;Acceptability of wearing cuffless BP devices using a (simple non-validated) Likert-type device wearability questionnaire.