HypertensionAVLA1NCT06446934
AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea
A study testing CPAP in people with Hypertension and Cardiac Function and Hemodynamics, run by Hospital Universitario Araba at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Hypertension, Cardiac Function and Hemodynamics, Usability
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 25-70 years old
- Moderate-severe OSA (AHI 15+)
- First prescription of CPAP therapy
- Undiagnosed HBP
- Smartphone use and technological skills
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, 01004
Mikel Azpiazu, MD, 945 005 916 ext. +34, migueljavier.azpiazublocona@osakidetza.eus
Mikel Azpiazu, MD
About this study
Official title: 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.
Read more
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
Read the 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.
- Being tested
- CPAP
- Keywords
- Hypertension, Obstructive Sleep Apnea, Blood Pressure Monitors, Continuous Positive Airway Pressure, Echocardiography, Pulse Wave Analysis, Photoplethysmography, Telemedicine
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Initial CPAP titration and subsequent CPAP therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Other | Interventional pre-post CPAP therapy Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm, interventional pre-post design study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Araba
- Sponsor type
- University, hospital or other
- Collaborators
- Bioaraba Health Research Institute
- Responsible party
- Principal investigator, Mikel Azpiazu, Hospital Universitario Araba
- Investigators
- Mikel Azpiazu, MD, Principal investigator, Hospital Universitario Araba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446934
- Sponsor's protocol ID
- PS2023034
- Acronym
- AVLA1
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data (IPD) that underlie results in a publication
Publications
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.
PubMed 35655524Tadic 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.
PubMed 35695237Bazzano 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.
PubMed 17548722Bradley 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.
PubMed 19101028
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continual Optical Cuffless Monitoring to Assess the CPAP Therapeutic Effect on Blood Pressure in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT06446934
- Acronym / sponsor ID
- AVLA1 / PS2023034
- Keywords
- Hypertension, Obstructive Sleep Apnea, Blood Pressure Monitors, Continuous Positive Airway Pressure, Echocardiography, Pulse Wave Analysis, Photoplethysmography, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Universitario ArabaUniversity, hospital or other
- Collaborators
- Bioaraba Health Research Institute
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, interventional pre-post design study
| Arm | Type | Receives |
|---|---|---|
| CPAP | Other | Device: CPAPInterventional pre-post CPAP therapy |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 25-70 years old
- Moderate-severe OSA (AHI 15+)
- First prescription of CPAP therapy
- Undiagnosed HBP
- Smartphone use and technological skills
Key exclusion criteria (8 listed)
- Antihypertensive drug
- Cardiovascular comorbidity: atrial fibrilation, heart failure, ischemic heart disease, stroke
- Reduced perfusion (e.g. Raynaud)
- Severe/Advanced chronic disease
- Central apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPInitial CPAP titration and subsequent CPAP therapy for 12 weeks | Device | CPAP |
Primary outcome
Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks
Time frame: 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM
Change in 24h/7d average SBP from week 0 (pre-CPAP) to week 12 (post-CPAP). SBP expressed in mmHg (millimeters of mercury)
1 secondary outcome
Change from baseline in the left ventricular global longitudinal strain (LV-GLS) at 12 weeks
Time frame: Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 35655524Sola 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.
- Background: PubMed 35695237Tadic 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.
- Background: PubMed 17548722Bazzano 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.
- Background: PubMed 19101028Bradley 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.
- Individual participant dataSharing planned: Yes. All Individual Participant Data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikel Azpiazu, MD principal investigator
Hospital Universitario Araba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Hypertension and Cardiac Function and Hemodynamics, run by Hospital Universitario Araba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikel Azpiazu, MD (945 00 59 16 ext. +34, migueljavier.azpiazublocona@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks (time frame: 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446934, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.