Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT05835232
Status:
UNKNOWN
Last Update Posted:
2023-04-28
First Post:
2023-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Disorders and Psychophysical Well-being in HIV+ Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': '1 year', 'description': 'It will investigate with the Italian version of the Pittsburgh Sleep Quality Index (PSQI) the quality of sleep in HIV+ patients by assessing the reported subjective quality, latency, duration, efficiency, degree of disturbed sleep, use of sleep medications, and how much sleep-related problems affect daily routines.'}], 'secondaryOutcomes': [{'measure': 'Influence of sleep quality on mental health', 'timeFrame': '1 year', 'description': 'Mental health will be investigated using the Depression Anxiety Stress Scale (DASS) 21, a self-assessment instrument containing 21 useful items to investigate three constructs: depression, anxiety and stress. Each construct constitutes a specific subscale, consisting of 7 items. Each item corresponds to a statement, referring to the past week.'}, {'measure': 'Influence of sleep quality on quality of life', 'timeFrame': '1 year', 'description': 'Quality of life will be investigated using the 12-item Short-Form Health Survey (SF-12). The SF-12 investigates quality of life with 12 items: 6 items are concerned with physical health (physical functioning, physical plane limitations, physical pain, general health) and 6 items are concerned with mental health (emotional plane limitations, fatigue or lack of energy, social functioning, emotional well-being).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The primary goal of this observational study is to investigate sleep quality in patients living with HIV+. The secondary objective is to measure the influence of sleep quality on indicators of mental health (anxiety, depression and stress) and quality of life.\n\nThe main questions it aims to answer are:\n\n* Measuring the effects of poor sleep quality on mental and physical health in HIV+ patients.\n* Monitor the sleep pattern in the HIV+ population.\n\nParticipants will fill out an online cross-sectional survey.\n\nThe online questionnaire survey will collect:\n\n* sociodemographic and clinical data related to HIV infection,\n* sleep quality,\n* mental health,\n* quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We expect the majority of the HIV patient population to be male, between the ages of 40 and 65 and with a high school diploma. We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy. We expect poor sleep quality and low quality of life and high symptoms of depression, anxiety and stress.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV diagnosis.\n* Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.\n* Ongoing antiretroviral therapy.\n* Age \\> 18 years.\n* Native Italian speaker.\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* Absence of an HIV diagnosis.\n* Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.\n* Absence of ongoing antiretroviral therapy.\n* Age \\> 18 years.\n* Not being a native Italian speaker.\n* Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05835232', 'acronym': 'DISOMETA', 'briefTitle': 'Sleep Disorders and Psychophysical Well-being in HIV+ Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Sleep Disorders, Mental Health and Quality of Life in a Court of HIV+ Patients', 'orgStudyIdInfo': {'id': '5250'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Each participant completed an anonymous 62-item online survey.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Valentina Delle Donne', 'role': 'CONTACT', 'email': 'valentina.delledonne1@unicatt.it', 'phone': '0630155366'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}