Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Blood Pressure Monitor

Hypertension Clinical Trial

— OBPM_HTN2024  

Official title:

OBPM_HTN2024 Study Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Optical Blood Pressure Monitoring (OBPM) Device: a Prospective Observational Clinical Study Across the United States

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356077
• Other study ID #: OBPM_HTN2024
• Status: Not yet recruiting
• Start date: July 15, 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Aktiia SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

OBPM_HTN2024 study was designed by AKTIIA SA to evaluate how a hypertensive population, reflective of the United States and encompassing a range of phenotypes, perceives the Aktiia 24/7 device (Aktiia G1) during their first 3 months of use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Adult subjects aged 21 to 85 years old

2. Hypertensive subjects either:

• Stage 1: SBP 145-159 mmHg or DBP 90-99 mmHg; or
• Stage 2: SBP 160-179 mmHg or DBP 100-109 mmHg; or
• Stage 3: SYS = 180mmHg and DIA = 110mmHg

3. Subjects living in the US

4. Subjects that can read and speak English

5. Subjects that own a smart phone that uses either the iOS or Android operating system

6. Subjects agreeing to follow study procedures

7. Subjects that have signed the informed consent form

Exclusion Criteria:

1. Subjects with tachycardia (heart rate at rest > 120bpm)

2. Subjects with atrial fibrillation

3. Cardio myopathy (FE<40%)

4. Severe valvular disease

5. Implanted devices such as a pacemaker or defibrillator

6. Subjects with diabetes

7. Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2)

8. Subjects with hyper-/hypothyroidism

9. Subjects with pheochromocytoma

10. Subjects with Raynaud's disease

11. Subjects with an arteriovenous fistula

12. Women in known pregnancy

13. Subjects with trembling and shivering

14. Subjects with lymphoedema

15. Low or elevated potassium level: threshold =3.5 mmol/L or =4.8 mmol/L

16. Presence of an intravascular device

17. Subjects with exfoliative skin diseases

18. Subjects with arm paralysis

19. Subjects with arm amputation

20. Subjects with upper arm circumference < 22cm or > 42cm

21. Subjects with wrist circumference > 23cm

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aktiia SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor	Number of participants with preferences using Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor to monitor their blood pressure.	3 months
Primary	Frequency of Aktiia app use	Number of of blood pressure data checks on the Aktiia mobile app per week (0 / 1-5 / 6-10 / 11-20 / 20+)	3 months
Primary	Frequency of use of Aktiia device as compared to previously use other blood pressure monitors	Position of each subject regarding whether they think they have used the Aktiia device more frequently as compared to other blood pressure monitors previously used out of study context (Yes/No)	3 months
Secondary	Evaluation of subject's experience in using the Aktiia App	Description of the study subject regarding their experience using the Aktiia Mobile App (It was very difficult to use / It was somewhat difficult to learn to use / It was neither easy nor difficult / It is easy to use / It was very easy to use)	3 months
Secondary	Evaluation of the most valuable data on the Aktiia Mobile App by subjects	Most valuable Aktiia app data according to subjects (Daily averages / Weekly averages / Monthly averages / Percent of BP time in target range /Day vs night blood pressure comparison /Visual graph of values)	3 months