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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-19', 'size': 109631, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-31T12:25', 'hasProtocol': False}, {'date': '2023-05-19', 'size': 121384, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-31T12:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-center, single-arm, interventional pre-post design study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from OSA diagnosis in Epworth Sleepiness Scale scoring at 12 weeks', 'timeFrame': 'Baseline at OSA diagnosis (pre-CPAP) and at the end of 12 weeks AKTIIA OBPM (post-CPAP)', 'description': '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.'}, {'measure': 'Usability of AKTIIA system and Patient Experience with AKTIIA OBPM at 12 weeks', 'timeFrame': 'At the end of 12 weeks AKTIIA OBPM', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks', 'timeFrame': '1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM', 'description': 'Change in 24h/7d average SBP from week 0 (pre-CPAP) to week 12 (post-CPAP). SBP expressed in mmHg (millimeters of mercury)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the left ventricular global longitudinal strain (LV-GLS) at 12 weeks', 'timeFrame': 'Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Obstructive Sleep Apnea', 'Blood Pressure Monitors', 'Continuous Positive Airway Pressure', 'Echocardiography', 'Pulse Wave Analysis', 'Photoplethysmography', 'Telemedicine'], 'conditions': ['Hypertension', 'Cardiac Function and Hemodynamics', 'Usability', 'Patient Experience']}, 'referencesModule': {'references': [{'pmid': '35655524', 'type': 'BACKGROUND', 'citation': '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': '35695237', 'type': 'BACKGROUND', 'citation': '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': '17548722', 'type': 'BACKGROUND', 'citation': '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': '19101028', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nIt 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.\n\nThe main questions it aims to answer are:\n\n* Does CPAP reduce systolic BP (and other BP metrics) in this population?\n* 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.\n\nParticipants will:\n\n* Take a CPAP titration and telemonitoring program for 12 weeks (from the titration date)\n* Take an AKTIIA OBPM one week before CPAP and 12 weeks since CPAP titration date\n* Take a STE test twice, before starting CPAP and 12 weeks after CPAP titration date\n* Take an online survey about easy of use and patient experience with AKTIIA OBPM device', 'detailedDescription': '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).\n\nIf 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.\n\nThe 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).\n\nFinally, an anonymous electronic survey on AKTIIA device usability and patient experience with AKTIIA OBPM and CPAP therapy will be conducted.\n\nWithdrawal 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.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 25-70 years old\n* Moderate-severe OSA (AHI 15+)\n* First prescription of CPAP therapy\n* Undiagnosed HBP\n* Smartphone use and technological skills\n* Informed consent\n\nExclusion Criteria:\n\n* Antihypertensive drug\n* Cardiovascular comorbidity: atrial fibrilation, heart failure, ischemic heart disease, stroke\n* Reduced perfusion (e.g. Raynaud)\n* Severe/Advanced chronic disease\n* Central apnea\n* Pregnancy\n* Shift work\n* Other social issues: misunderstanding/miscommunication'}, 'identificationModule': {'nctId': 'NCT06446934', 'acronym': 'AVLA1', 'briefTitle': 'AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Araba'}, 'officialTitle': 'Continual Optical Cuffless Monitoring to Assess the CPAP Therapeutic Effect on Blood Pressure in Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'PS2023034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CPAP', 'description': 'Interventional pre-post CPAP therapy', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'Initial CPAP titration and subsequent CPAP therapy for 12 weeks', 'armGroupLabels': ['CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01004', 'city': 'Vitoria-Gasteiz', 'state': 'Araba', 'country': 'Spain', 'contacts': [{'name': 'Mikel Azpiazu, MD', 'role': 'CONTACT', 'email': 'migueljavier.azpiazublocona@osakidetza.eus', 'phone': '945 005 916', 'phoneExt': '+34'}, {'name': 'Mikel Azpiazu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fernando Ereño, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'centralContacts': [{'name': 'Mikel Azpiazu, MD', 'role': 'CONTACT', 'email': 'migueljavier.azpiazublocona@osakidetza.eus', 'phone': '945 00 59 16', 'phoneExt': '+34'}], 'overallOfficials': [{'name': 'Mikel Azpiazu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Araba'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'All Individual Participant Data (IPD) that underlie results in a publication', 'accessCriteria': '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.\n\nAccess 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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Araba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bioaraba Health Research Institute', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Mikel Azpiazu', 'investigatorAffiliation': 'Hospital Universitario Araba'}}}}