MedTrace Logo

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

NCT06446934 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-06-06

No results posted yet for this study

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

Conditions

  • Hypertension
  • Cardiac Function and Hemodynamics
  • Usability
  • Patient Experience

Interventions

DEVICE

CPAP

Initial CPAP titration and subsequent CPAP therapy for 12 weeks

Sponsors & Collaborators

  • Bioaraba Health Research Institute

    collaborator NETWORK

  • Hospital Universitario Araba

    lead OTHER

Principal Investigators

  • Mikel Azpiazu, MD · Hospital Universitario Araba

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446934 on ClinicalTrials.gov