AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea (AVLA1)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Usability; Patient Experience; Cardiac Function and Hemodynamics
• Intervention / Treatment: Device: CPAP

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikel Azpiazu, MD; Phone Number: +34 945 00 59 16; Email: migueljavier.azpiazublocona@osakidetza.eus

Study Locations

• Spain
  • Araba
    • Vitoria-Gasteiz, Araba, Spain, 01004
      • Hospital Universitario Araba
      • Contact: Mikel Azpiazu, MD; Phone Number: +34 945 005 916; Email: migueljavier.azpiazublocona@osakidetza.eus
      • Principal Investigator: Mikel Azpiazu, MD
      • Sub-Investigator: Fernando Ereño, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CPAP; Interventional pre-post CPAP therapy	Device: CPAP; Initial CPAP titration and subsequent CPAP therapy for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Hospital Universitario Araba
• Collaborators: Bioaraba Health Research Institute
• Investigators: Principal Investigator: Mikel Azpiazu, MD, Hospital Universitario Araba

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Hypertension; Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Photoplethysmography; Echocardiography; Blood Pressure Monitors; Pulse Wave Analysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
• Other Study ID Numbers: PS2023034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Participant Data (IPD) that underlie results in a publication
• IPD Sharing Time Frame: Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in sleep apnea, HBP or AKTIIA OBPM. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact to migueljavier.azpiazublocona@osakidetza.eus

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No