Cardiac Function and Hemodynamics, Hypertension, Patient Experience, Usability
Conditions
Keywords
Hypertension, Obstructive Sleep Apnea, Blood Pressure Monitors, Continuous Positive Airway Pressure, Echocardiography, Pulse Wave Analysis, Photoplethysmography, Telemedicine
Brief 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
Detailed description
Patients with moderate-severe OSA, indication for CPAP therapy and undiagnosed hypertension will be included. If the patient meets all the inclusion criteria and none of the exclusion criteria, he/she will be considered a candidate for the study. Once the informed consent has been signed, a visit will be made to initiate continuous blood pressure monitoring with the AKTIIA system (AKTIIA OBPM). The first week (week 0, preCPAP) serves to confirm the presence of HBP (average BP 130/80+ mmHg and/or average nocturnal BP 120/70+ mmHg). If the participant has HBP criteria, an speckle tracking echocardiography (STE) will be performed (preCPAP) and then CPAP treatment will be initiated following the sleep unit´s telemonitoring care program with initial ambulatory pressure titration. If the participant do not have HBP criteria, only CPAP treatment will be started. The CPAP titration date will be day 1 for AKTIIA OBPM and CPAP monitoring. At 12 weeks of monitoring, a second STE will be scheduled (post-CPAP) and the end-of-study on-site visit is performed to assess: efficacy and adherence to CPAP, clinical and BP control in the AKTIIA OBPM (week 12, post-CPAP). Finally, an anonymous electronic survey on AKTIIA device usability and patient experience with AKTIIA OBPM and CPAP therapy will be conducted. Withdrawal criteria are: ineffective CPAP titration, CPAP dropout, invalid AKTIIA OBPM or dropout, prescription of antihypertensive drug, patient decision or PI decision and loss of contact. Researchers will compare pre-post CPAP blood pressure metrics (systolic BP as the main parameter), circadian profile, dynamic metrics, STE metrics, efficacy and CPAP adherence, symptoms (ESS, QOL own scales) and subgroup analysis by gender, age, OSA severity or CPAP adherence.
Interventions
DEVICECPAP
Initial CPAP titration and subsequent CPAP therapy for 12 weeks
Sponsors
Bioaraba Health Research Institute
Hospital Universitario Araba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, single-arm, interventional pre-post design study
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks | 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM | Change in 24h/7d average SBP from week 0 (pre-CPAP) to week 12 (post-CPAP). SBP expressed in mmHg (millimeters of mercury) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the left ventricular global longitudinal strain (LV-GLS) at 12 weeks | Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from OSA diagnosis in Epworth Sleepiness Scale scoring at 12 weeks | Baseline at OSA diagnosis (pre-CPAP) and at the end of 12 weeks AKTIIA OBPM (post-CPAP) | 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. |
| Usability of AKTIIA system and Patient Experience with AKTIIA OBPM at 12 weeks | At the end of 12 weeks AKTIIA OBPM | 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. |
Countries
Spain
Contacts
Primary ContactMikel Azpiazu, MD
Outcome results
None listed