Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT06446934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea
Sponsor:
Hospital Universitario Araba
Organization:
Study Overview
Official Title:
Continual Optical Cuffless Monitoring to Assess the CPAP Therapeutic Effect on Blood Pressure in Obstructive Sleep Apnea Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVLA1
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: