COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

NCT05211648 | Completed FDA Device

• 1 other identifier: OBPM_Remote2021
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote Hypertension Program. The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring to those measured automatically by the Aktiia bracelet.

Conditions

Hypertension

Keywords

hypertension

Outcome Measures

Primary Outcomes (2)

• Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.

  Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.

  6 months

• Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.

  Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.

  6 months

Secondary Outcomes (2)

• Diastolic and Systolic Pressures Circadian profiles

  6 months

• Quality of life surveys

  6 months

Study Arms (1)

Patients with Aktiia bracelet

EXPERIMENTAL

This is a prospective open-label single arm study. Study participants will wear the Aktiia bracelet for 6 months and will continue in parallel the procedures of the Remote Hypertension Program.

Device: Aktiia Bracelet

Interventions

Aktiia Bracelet DEVICE

Aktiia Bracelet is a CE-marked medical device that will be used in accordance with its instructions for use. The optical signals at the wrist are recorded non-invasively by means by the Aktiia bracelet. The Blood Pressure measurements are further determined from these optical signals and are compared to weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring.

Patients with Aktiia bracelet

Eligibility Criteria

• Age: 26 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in written and spoken English
• Already enrolled in the Remote Hypertension Program
• Average of last 3 office blood pressures \>140/90 mm Hg in last 18 months OR Last office blood pressure \>140/90 mm Hg in last 6 months OR Referred by MD and last 1 blood pressure \>130/80 mm Hg
• Own an iPhone

You may not qualify if:

• Tachycardia (heart rate at rest \> 120bpm)
• Atrial fibrillation, persistent
• Severe heart failure (LVEF\<35%)
• Pheochromocytoma
• Raynaud's disease
• Trembling and shivering
• Known pregnancy
• Breastfeeding
• Arteriovenous fistula
• Arm amputation
• Exfoliative skin disease
• Lymphoedema
• Known allergy to silicone
• Not Massachusetts resident
• Last MGB office visit \>3 years

Sponsors & Collaborators

• Aktiia SA: lead

Study Sites (1)

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Naomi Fisher, MD

  Harvard Medical School Boston MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective open-label single arm study.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 27, 2022
• Study Start: February 10, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)