HypertensionNCT05211648
COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
A study testing Aktiia Bracelet in people with Hypertension, run by Aktiia SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aktiia Bracelet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 23 May 2023
- Phase
- Interventional
- 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 26 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Tachycardia (heart rate at rest > 120bpm)
- Atrial fibrillation, persistent
- Severe heart failure (LVEF<35%)
- Pheochromocytoma
- Raynaud's disease
- Trembling and shivering
Show all 18Show fewer
- Known pregnancy
- Breastfeeding
- Arteriovenous fistula
- Arm amputation
- Exfoliative skin disease
- Lymphoedema
- Known allergy to silicone
- Not Massachusetts resident
- Last MGB office visit >3 years
- No-MGB provider
- Terminal medical condition
- CKD 4-5 (eGFR ≤ 30 mL/mn)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate.
Participants who consent to participate in COOL-BP will be shipped an Aktiia device to participants' residence.
For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring.
Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program.
- Conditions
- Hypertension
- Being tested
- Aktiia Bracelet
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia BraceletDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Aktiia Bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Diastolic and Systolic Pressures Circadian profiles
Analysis of the evolution of Diastolic and Systolic Pressures circadian profiles of each patient during the study.
Measured: 6 months
Quality of life surveys
Participants complete the same survey at Day 30, Day 60 and Day 180 to give a feedback on participants' satisfaction and comfort regarding Aktiia product compared to Home Blood Pressure monitoring. Part of answers to surveys are based on satisfaction scales from 0 to 10 where 0 = "bad" and 10 = "good".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Feb 2022
- Primary completion23 May 2023
- Study completion23 May 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective open-label single arm study.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi Fisher, MD, Principal investigator, Harvard Medical School Boston MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211648
- Sponsor's protocol ID
- OBPM_Remote2021
- Status last verified
- May 2023
- First submitted
- 23 Dec 2021
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL-BP Study: Continuous Versus Occasional Blood Pressure Study
- ClinicalTrials.gov ID
- NCT05211648
- Acronym / sponsor ID
- OBPM_Remote2021
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 27 Jan 2022 (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 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.
Detailed description
This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate.
Participants who consent to participate in COOL-BP will be shipped an Aktiia device to participants' residence.
For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring.
Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective open-label single arm study.
| Arm | Type | Receives |
|---|---|---|
| Patients with Aktiia bracelet | Experimental | Device: Aktiia BraceletThis 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. |
Who may qualify
- Ages
- 26 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Tachycardia (heart rate at rest > 120bpm)
- Atrial fibrillation, persistent
- Severe heart failure (LVEF<35%)
- Pheochromocytoma
- Raynaud's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aktiia BraceletAktiia 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. | Device | Patients with Aktiia bracelet |
Primary outcome
Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
Time frame: 6 months
Diastolic and Systolic Pressures are measured weekly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.
Diastolic and Systolic Pressures differences between monthly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data.
Time frame: 6 months
Diastolic and Systolic Pressures are measured monthly manually by traditional Home Blood Pressure Monitoring and continuously with the Aktiia bracelet.
2 secondary outcomes
Diastolic and Systolic Pressures Circadian profiles
Time frame: 6 months
Quality of life surveys
Time frame: 6 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 24 May 2023.
- Individual participant dataSharing planned: No
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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.
Naomi Fisher, MD principal investigator
Harvard Medical School Boston MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia Bracelet in people with Hypertension, run by Aktiia SA at 1 site in United States.
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 4 inclusion and 18 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 24 May 2023. 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 States. 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?
Diastolic and Systolic Pressures differences between weekly Diastolic and Systolic pressures averages provided by Home Blood Pressure Monitoring and by Aktiia 24h data. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 May 2023.