Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT05742360
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The blood samples will be used to determine levels of BP medications and serum creatinine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 227}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24-hour Mean Blood Pressure', 'timeFrame': 'Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy', 'description': '24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)'}], 'secondaryOutcomes': [{'measure': 'Nocturnal Mean BP', 'timeFrame': 'Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy', 'description': 'Nocturnal Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)'}, {'measure': 'Reciprocal of Reaction Time', 'timeFrame': 'Change from baseline reaction time at 6-months after initiation of CPAP therapy', 'description': 'Reciprocal of reaction time obtained by Psychomotor Vigilance Test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excessively Sleepy Symptom Subtype'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.', 'detailedDescription': 'This is a prospective, non-randomized, observational, two-center study involving newly diagnosed subjects with moderate-severe OSA with the excessively sleepy symptom subtype.\n\nVariables of Interest: Change in 24-hour ambulatory BP, change in sitting BP, change in reaction time by psychomotor vigilance test (PVT)\n\nParticipants will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities. The blood samples will be used to determine levels of BP medications and serum creatinine. Measurements will be collected at baseline and at 6-month follow-up visits.\n\nData Analysis Approach: To correct for potential bias in the non-randomized comparison, the investigators will apply a Propensity Score (PS) Design via subclassification. Models to derive the PS values used in this design will include a number of covariates relevant to CPAP adherence, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, history of hypertension, diabetes mellitus (history, medications), lipid profile, hyperlipidemia (history, medications), family history of premature coronary disease, Charlson comorbidity index, physical activity (IPAQ), diet, OSA severity (AHI, ODI4, T90), sleepiness (Epworth Sleepiness Scale), educational attainment, socioeconomic status (postcode), insomnia symptoms (Insomnia Symptom Questionnaire), anxiety and depression-related symptoms (Patient Health Questionnaire-2), self-efficacy (General self-efficacy scale), and medication adherence (Medication Adherence Report Scale \\[MARS-5\\]). Baseline values of outcome measures will also be included in the PS model. After creating the PS design, all analyses are performed accounting for PS subclass as a categorical stratification factor. Evaluations of the CPAP effect on binary outcomes are performed utilizing conditional logistic regression. Similarly, CPAP effects in the context of survival analyses (e.g., Cox Proportional Hazards models) or on continuous outcomes (e.g., linear regression) are assessed by including PS subclass as a categorical covariate in all models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults between the ages of 18 to 75 years old with moderate-severe obstructive sleep apnea (OSA) with excessively sleepy symptom subtype. OSA diagnosis will be defined as an apnea/hypopnea index (AHI) \\>or =5 episodes per hour.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Moderate-severe OSA (defined as ODI ≥10 events/hour) via Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) done based on clinical grounds\n* Excessively sleepy subtype determined by patient-reported symptoms\n* Willing to accept CPAP therapy\n* An elevated baseline office BP defined as ≥120 or ≥80 mmHg\n* Planned PAP (CPAP or bi-level PAP) treatment by treating provider\n\nExclusion Criteria:\n\n* Recent changes (within 3 months) to BP medications among those who are on these medications\n* Unable to apply ABPM cuff\n* Current use of CPAP or other OSA treatments\n* Resting, awake SaO2 \\<90% or use of home oxygen therapy\n* New York Heart Association (NYHA) categories III-IV of heart failure\n* Presence of Cheyne-Stokes Respiration (CSR) in sleep study identified by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation\n* Predominantly central sleep apnea (AHI≥15 events/hour, with \\>50% central events \\[apnea or hypopnea\\])\n* Life expectancy \\<2 years\n* Pregnancy\n* Clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant\n* Systolic BP \\> 180 mmHg'}, 'identificationModule': {'nctId': 'NCT05742360', 'briefTitle': 'Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype', 'orgStudyIdInfo': {'id': '2022H0323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA subjects with the excessively sleepy symptom subtype treated with CPAP', 'description': 'Patients with the excessively sleepy symptom subtype who accept CPAP therapy', 'interventionNames': ['Device: CPAP therapy']}], 'interventions': [{'name': 'CPAP therapy', 'type': 'DEVICE', 'description': 'CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype', 'armGroupLabels': ['OSA subjects with the excessively sleepy symptom subtype treated with CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alicia Gonzalez Zacarias, MD', 'role': 'CONTACT', 'email': 'alicia.gonzalezzacarias@osumc.edu', 'phone': '6143662361'}, {'name': 'Joseph Santiago, RRT', 'role': 'CONTACT', 'email': 'joseph.santiago@osumc.edu', 'phone': '6143664756'}, {'name': 'Ulysses Magalang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allan I Pack, MBChB', 'role': 'CONTACT', 'email': 'pack@pennmedicine.upenn.edu', 'phone': '2157464806'}, {'name': 'Colleen Walsh', 'role': 'CONTACT', 'email': 'walshco@pennmedicine.upenn.edu', 'phone': '2157464806'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Alicia Gonzalez Zacarias, MD', 'role': 'CONTACT', 'email': 'alicia.gonzalezzacarias@osumc.edu', 'phone': '6143662361'}, {'name': 'Joseph Santiago, RRT', 'role': 'CONTACT', 'email': 'joseph.santiago@osumc.edu', 'phone': '6143664756'}], 'overallOfficials': [{'name': 'Ulysses Magalang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Ulysses Magalang MD', 'investigatorAffiliation': 'Ohio State University'}}}}