protocolSection identificationModule nctId: NCT06302738, orgStudyIdInfo id: 09C221, briefTitle: Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern, acronym: INTO-DIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI\>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension., conditionsModule conditions: Hypertension, conditions: Sleep Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 143, type: ESTIMATED, armsInterventionsModule interventions name: polysomnography, outcomesModule primaryOutcomes measure: Prevalence of sleep disorders, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,, status: RECRUITING, city: Bari, state: Italy, Bari, zip: 70120, country: Italy, contacts name: Sebastiano Cicco, MD, role: CONTACT, email: sebastiano.cicco@uniba.it, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Azienda Sanitaria Locale della provincia di Brindisi, status: RECRUITING, city: Brindisi, state: Italy, Brindisi, zip: 72100, country: Italy, contacts name: Luigi Vernaglione, MD, role: CONTACT, phone: 003908311882006, geoPoint lat: 40.63215, lon: 17.93607, locations facility: Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara, status: RECRUITING, city: Novara, state: Italy, Novara, zip: 28100, country: Italy, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy, status: RECRUITING, city: Padova, state: Italy, Padova, zip: 35128, country: Italy, contacts name: Maria Teresa Seccia, MD, PhD, role: CONTACT, phone: 00390498212263, email: teresamaria.seccia@unipd.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy, status: RECRUITING, city: Padova, state: Italy, Padova, zip: 35128, country: Italy, contacts name: Giuseppe Maiolino, MD, role: CONTACT, phone: 00390498212872, email: giuseppe.maiolino@gmail.com, geoPoint lat: 45.40797, lon: 11.88586, locations facility: UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy., status: NOT_YET_RECRUITING, city: Cittadella, state: Italy, PD, zip: 35013, country: Italy, contacts name: Francesca Saladini, MD, role: CONTACT, phone: 00390499424531, email: francesca.saladini@alss6.veneto.it, geoPoint lat: 45.64523, lon: 11.78453, locations facility: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare, status: NOT_YET_RECRUITING, city: Reggio Emilia, state: Italy, RE, zip: 42122, country: Italy, contacts name: Chiara Grasselli, MD, role: CONTACT, email: chiara.grasselli@ausl.re.it, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto, status: NOT_YET_RECRUITING, city: Rovereto, state: Italy, Trento, zip: 38068, country: Italy, contacts name: Francesco Dalle Vedove, MD, role: CONTACT, geoPoint lat: 45.8904, lon: 11.04053, locations facility: Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica, status: NOT_YET_RECRUITING, city: Trieste, state: Italy, Trieste, zip: 34128, country: Italy, contacts name: Andrea Grillo, MD, PhD, role: CONTACT, phone: 00390403994619, email: andrea.grillo@asugi.sanita.fvg.it, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Department of Medicine, University of Verona, Verona, Italy, status: RECRUITING, city: Verona, state: Italy, Verona, zip: 37126, country: Italy, contacts name: Cristiano Fava, MD, PhD, role: CONTACT, phone: 00390458124732, email: cristiano.fava@univr.it, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milano, state: MI, zip: 20149, country: Italy, contacts name: Martino Pengo, MD, PhD, role: CONTACT, phone: 00390261911, email: m.pengo@auxologico.it, contacts name: Elisa Nardin, role: CONTACT, phone: 00390261911, email: e.nardin@auxologico.it, contacts name: Gianfranco Parati, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False