Hypertension Clinical Trial
— AVLA1Official title:
Continual Optical Cuffless Monitoring to Assess the CPAP Therapeutic Effect on Blood Pressure in Obstructive Sleep Apnea Patients
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
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | April 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Araba | Vitoria-Gasteiz | Araba |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Araba | Bioaraba Health Research Institute |
Spain,
Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4. — View Citation
Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26. — View Citation
Sola J, Cortes M, Perruchoud D, De Marco B, Lobo MD, Pellaton C, Wuerzner G, Fisher NDL, Shah J. Guidance for the Interpretation of Continual Cuffless Blood Pressure Data for the Diagnosis and Management of Hypertension. Front Med Technol. 2022 May 17;4:899143. doi: 10.3389/fmedt.2022.899143. eCollection 2022. — View Citation
Tadic M, Gherbesi E, Faggiano A, Sala C, Carugo S, Cuspidi C. The impact of continuous positive airway pressure on cardiac mechanics: Findings from a meta-analysis of echocardiographic studies. J Clin Hypertens (Greenwich). 2022 Jul;24(7):795-803. doi: 10.1111/jch.14488. Epub 2022 Jun 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from OSA diagnosis in Epworth Sleepiness Scale scoring at 12 weeks | Change in ESS scoring from OSA diagnosis (pre-CPAP) to ESS scoring at the end of 12 weeks (post-CPAP). The ESS score is based on 8 questions and a scale of 0 to 24. The scale estimates whether the participants are experiencing excessive sleepiness due to OSA and its improvement with CPAP therapy. A normal score (no diurnal sleepiness) is less than 11 points. | Baseline at OSA diagnosis (pre-CPAP) and at the end of 12 weeks AKTIIA OBPM (post-CPAP) | |
Other | Usability of AKTIIA system and Patient Experience with AKTIIA OBPM at 12 weeks | Participants answer an anonymous survey of several questions about the usability of the AKTIIA system and their experience and opinion about continuous blood pressure monitoring for 12 weeks. The questions are asked on a Likert scale from 1 to 5, with 5 being the best satisfaction/opinion. | At the end of 12 weeks AKTIIA OBPM | |
Primary | Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks | Change in 24h/7d average SBP from week 0 (pre-CPAP) to week 12 (post-CPAP). SBP expressed in mmHg (millimeters of mercury) | 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM | |
Secondary | Change from baseline in the left ventricular global longitudinal strain (LV-GLS) at 12 weeks | Change in LV-GLS from pre-CPAP speckle tracking echocardiography (STE) to post-CPAP STE at week 12 (post-CPAP). LV-GLS values are reported as absolute numbers. By convention, GLS is expressed as a negative number (normal range, -19% to -20%), and more negative LV GLS values represent better systolic performance. | Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM |
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