Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 2:18 PM
Study NCT ID:
NCT07018557
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Efficacy of insomnia treatment on blood pressure based on the type of insomnia', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on blood pressure according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia).'}, {'measure': 'Efficacy of insomnia treatment on blood pressure according to sleep apnea status', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on blood pressure in patients with and without sleep apnea.'}], 'primaryOutcomes': [{'measure': 'Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on 24-h blood pressure by ABPM (mmHg).'}], 'secondaryOutcomes': [{'measure': 'Efficacy of insomnia treatment on daytime and nighttime blood pressure (evaluated by Ambulatory blood pressure monitoring)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on daytime and nighttime blood pressure BP (mmHg).'}, {'measure': 'Efficacy of insomnia treatment on 24-h, daytime, and nighttime BP control (evaluated by Ambulatory blood pressure monitoring)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on 24-h, daytime, and nighttime BP control (%).'}, {'measure': 'Efficacy of insomnia treatment on non-dipping BP pattern (evaluated by Ambulatory blood pressure monitoring)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on non-dipping BP (%).'}, {'measure': 'Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on office BP (mmHg).'}, {'measure': 'Efficacy of insomnia treatment on sleep quality (evaluated by Pittsburgh Sleep Quality Index)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on sleep quality (absolute values).'}, {'measure': 'Efficacy of insomnia treatment on insomnia severity (evaluated by insomnia severity index)', 'timeFrame': '3 months', 'description': 'To assess the impact of treatment of insomnia with eszopiclone on insomnia severity (absolute values).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Hypertension', 'Blood Pressure', 'Treatment'], 'conditions': ['Insomnia', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Insomnia is a common sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite appropriate opportunities for getting sleep. Growing evidence has associated insomnia with prevalent and incidence of hypertension. However, the impact of the pharmacologic treatment of insomnia on office blood pressure (BP) and 24-h ambulatory BP monitoring (ABPM) in unclear. Therefore, the aim of this study is to evaluate the impact of eszopiclone, a non-benzodiazepine hypnotic that binds to certain subunits of the gamma-aminobutyric acid type A receptors GABA-A (such as α1, α3, and α5) promoting relaxation and sleep. Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).', 'detailedDescription': 'We will consecutively evaluate the presence of insomnia in adult patients with hypertension under regular treatment recruited from the outpatient clinic at the Heart Institute (InCor).\n\nThe following exams will be made:\n\n1. Definition of the presence of insomnia following the criteria from DSM V and severity by the insomnia severity index.\n2. Evaluation of the Pittsburgh Sleep Quality Index.\n3. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.\n4. Evaluation of anxiety disorder by the Generalized Anxiety Disorder (GAD-7)\n5. Beck form for depression evaluation.\n6. Detection of sleep apnea using a portable monitor (BiologixTM) Patients that fulfilled the inclusion criteria will be submitted to a 1-month run-in period before randomization with pill counting for improving medical adherence and defining baseline BP. Then patients with be randomized to sleep hygiene + eszopiclone or sleep hygiene + placebo for 3 months (double-blind study design). We will collect demographic and anthropometric data, as well as concomitant comorbidities, medications, standard BP measurements (office and ABPM) at baseline and after 3 -months.\n\nThe main hypothesis is that pharmacological treatment, as compared to placebo, will be able to improve insomnia in parallel to a significant decrease in 24-h ABPM (primary outcome). We will also evaluate absolute decrease of daytime and nighttime BP, % of 24-h, daytime, and nighttime BP control, % non-dipping BP, office BP, sleep quality and improvement in insomnia severity index scale as secondary outcomes. Exploratory analysis evaluating the effects of eszopiclone according to the type of insomnia (initial or sleep-onset insomnia, middle or maintenance insomnia and terminal or late insomnia). We also explored whether the results will be influenced by the presence of untreated sleep apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (30 to 75 years-old)\n* BMI \\<40Kg/m2;\n* Availability to participate\n* History of HBP under regular treatment (systolic pressure between 130-160 and diastolic pressure between 80-100 mmHg).\n\nExclusion Criteria:\n\n* Use of benzodiazepines or "Z" drugs;\n* Night workers;\n* History of severe chronic obstructive pulmonary disease (COPD);\n* Heart failure (ejection fraction \\<40% on echocardiogram);\n* Prior stroke;\n* Generalized anxiety disorder (GAD-7 \\>14 points) and severe depression (Beck);\n* Severe liver disease;\n* Alcohol abuse;\n* Advanced chronic kidney disease 4 or 5 (glomerular filtration rate \\<30ml/min/1.73m2);\n* Patient who is on loop diuretics;\n* Patient with type 1 diabetes;\n* Patient with decompensated type 2 diabetes (Glycated hemoglobin \\>10%);\n* Urinuria Incontinence;\n* Prostatism;\n* History of active cancer;\n* Pregnancy;\n* Complex sleep behaviors, suicidal behavior.'}, 'identificationModule': {'nctId': 'NCT07018557', 'acronym': 'PRYSMA-HTN', 'briefTitle': 'Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)', 'orgStudyIdInfo': {'id': '73710523.3.0000.0068'}, 'secondaryIdInfos': [{'id': 'Investigator initiated Study', 'type': 'OTHER', 'domain': 'Heart Institute (InCor), University of Sao Paulo Medical School, Brazil'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + sleep hygiene', 'description': 'Placebo pill (identical to the active treatment) + sleep counseling for improving insomnia', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eszopiclone + sleep hygiene', 'description': 'Active treatment for insomnia + sleep counseling', 'interventionNames': ['Drug: Eszopiclone 3 mg']}], 'interventions': [{'name': 'Eszopiclone 3 mg', 'type': 'DRUG', 'description': 'Eszopiclone is an FDA-approved treatment for insomnia in those who have difficulty falling asleep and for patients with difficulty staying asleep (sleep maintenance).', 'armGroupLabels': ['Eszopiclone + sleep hygiene']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo pills identical to the active comparator.', 'armGroupLabels': ['Placebo + sleep hygiene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403900', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Amanda A Brito', 'role': 'CONTACT', 'email': 'amanda.abrito@hc.fm.usp.br', 'phone': '+5511976765005'}], 'facility': 'Academic Research Organization - Heart Institute (InCor)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'LUCIANO F DRAGER, MD, PhD', 'role': 'CONTACT', 'email': 'luciano.drager@incor.usp.br', 'phone': '+5511988027887'}], 'overallOfficials': [{'name': 'Luciano F. Drager, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eurofarma Laboratorios S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Luciano F Drager, MD, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}