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Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

NCT06302738 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2024-04-16

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

polysomnography

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

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Gianfranco Parati, MD · Istituto Auxologico Italiano IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302738 on ClinicalTrials.gov