UnknownNot Applicable

AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea

Spain90 participantsStarted 2024-06-01

Plain-language summary

The goal of this clinical trial is to learn if positive airway pressure (CPAP) therapy works for blood pressure (BP) control in obstructive sleep apnea (OSA) adult patients plus undiagnosed hypertension (HBP), using a cuffless bracelet for continual optical BP monitoring (AKTIIA OBPM). It will also learn if CPAP improves cardiac function in these patients using speckle tracking echocardiography (STE) and to learn about ease of use and patient experience with AKTIIA device and AKTIIA OBPM. The main questions it aims to answer are: * Does CPAP reduce systolic BP (and other BP metrics) in this population? * Does CPAP improve cardiac function in the same population? Researchers will compare BP metrics derived from AKTIIA OBPM and STE metrics in a before and after CPAP therapy to evaluate its therapeutic effect. Participants will: * Take a CPAP titration and telemonitoring program for 12 weeks (from the titration date) * Take an AKTIIA OBPM one week before CPAP and 12 weeks since CPAP titration date * Take a STE test twice, before starting CPAP and 12 weeks after CPAP titration date * Take an online survey about easy of use and patient experience with AKTIIA OBPM device

Who can participate

Age range

25 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults 25-70 years old * Moderate-severe OSA (AHI 15+) * First prescription of CPAP therapy * Undiagnosed HBP * Smartphone use and technological skills * Informed consent Exclusion Criteria: * Antihypertensive drug * Cardiovascular comorbidity: atrial fibrilation, heart failure, ischemic heart disease, stroke * Reduced perfusion (e.g. Raynaud) * Severe/Advanced chronic disease * Central apnea * Pregnancy * Shift work * Other social issues: misunderstanding/miscommunication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks

Timeframe: 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM

Trial details

NCT IDNCT06446934

SponsorHospital Universitario Araba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Mikel Azpiazu, MD

945 00 59 16 migueljavier.azpiazublocona@osakidetza.eus

View on ClinicalTrials.gov More Hypertension trials