Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06302738

Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

Sponsor: Istituto Auxologico Italiano

View on ClinicalTrials.gov

Summary

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.

Official title: PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

143

Start Date

2023-05-04

Completion Date

2024-12-31

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

polysomnography

patients will undergo a home sleep study to evaluate the presence of sleep disorders

Locations (11)

UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,

Bari, Italy, Bari, Italy

Azienda Sanitaria Locale della provincia di Brindisi

Brindisi, Italy, Brindisi, Italy

Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara

Novara, Italy, Novara, Italy

Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy

Padova, Italy, Padova, Italy

Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy

Padova, Italy, Padova, Italy

UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.

Cittadella, Italy, PD, Italy

Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare

Reggio Emilia, Italy, RE, Italy

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto

Rovereto, Italy, Trento, Italy

Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica

Trieste, Italy, Trieste, Italy

Department of Medicine, University of Verona, Verona, Italy

Verona, Italy, Verona, Italy

Istituto Auxologico Italiano IRCCS

Milan, MI, Italy