Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

NCT04027777 | Unknown DMC

• 1 other identifier: OBPM_Ambulatory2019
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Blood Pressure absolute Mean Error

  The absolute value of the mean of the differences between Reference and Aktiia.product-P0 blood pressure determinations

  Up to four weeks

• Blood Pressure standard Deviation of the Error

  The standard deviation of the differences between Reference and Aktiia.product-P0 determinations

  Up to four weeks

Secondary Outcomes (1)

• Heart Rate root-mean-square error

  Up to four weeks

Study Arms (3)

Aktiia.product-P0

EXPERIMENTAL

Main study arm including 85 subjects

Device: Aktiia.product-P0

Aktiia.product-P0 Diabetics

EXPERIMENTAL

Second study arm including 40 diabetic patients

Device: Aktiia.product-P0

Aktiia.product-P0 Aged

EXPERIMENTAL

Thirs study arm including 40 patients aged 65+

Device: Aktiia.product-P0

Interventions

Aktiia.product-P0 DEVICE

The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.

Aktiia.product-P0; Aktiia.product-P0 Aged; Aktiia.product-P0 Diabetics

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (aged between 21 and 65 years old)
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects that have signed the informed consent form

You may not qualify if:

• Subjects with tachycardia (heart rate at rest \> 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2)
• Subjects with hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference \> 15 mmHg
• Subjects with interarm diastolic difference \> 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference \> 64 cm

Sponsors & Collaborators

• Aktiia SA: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (1)

• Theiler K, Sola J, Damianaki A, Pfister A, Almeida TP, Alexandre J, Vermare P, Wuerzner G. Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions. Blood Press. 2023 Dec;32(1):2281320. doi: 10.1080/08037051.2023.2281320. Epub 2023 Nov 16.

  PMID: 37971487 DERIVED

Related Links

• Sponsor website

Study Officials

• Gregoire Wuerzner, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Sola, PhD

CONTACT

+41797689800; josep@aktiia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 22, 2019
• Study Start: August 6, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)