Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-27
Brief Title:
AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea
Sponsor:
Hospital Universitario Araba
Organization:
Hospital Universitario Araba
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 heshe 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 13080 mmHg andor average nocturnal BP 12070 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 units 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 units 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:
None
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?:
None