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

NCT06446934 | Not Yet Recruiting

• 1 other identifier: PS2023034
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Cardiac Function and Hemodynamics; Usability; Patient Experience

Keywords

Hypertension; Obstructive Sleep Apnea; Blood Pressure Monitors; Continuous Positive Airway Pressure; Echocardiography; Pulse Wave Analysis; Photoplethysmography; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• 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)

• Usability of AKTIIA system and Patient Experience with AKTIIA OBPM at 12 weeks

  At the end of 12 weeks AKTIIA OBPM

Study Arms (1)

CPAP

OTHER

Interventional pre-post CPAP therapy

Device: CPAP

Interventions

CPAP DEVICE

Initial CPAP titration and subsequent CPAP therapy for 12 weeks

CPAP

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 25-70 years old
• Moderate-severe OSA (AHI 15+)
• First prescription of CPAP therapy
• Undiagnosed HBP
• Smartphone use and technological skills
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• Bioaraba Health Research Institute: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01004, Spain

Location

Related Publications (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.

  PMID: 35655524 BACKGROUND

• 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.

  PMID: 35695237 BACKGROUND

• 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.

  PMID: 17548722 BACKGROUND

• 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.

  PMID: 19101028 BACKGROUND

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mikel Azpiazu, MD

  Hospital Universitario Araba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikel Azpiazu, MD

CONTACT

945 00 59 16; migueljavier.azpiazublocona@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single-center, single-arm, interventional pre-post design study

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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

Locations

ES (1)