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Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06302738
Acronym
INTO-DIP
Enrollment
143
Registered
2024-03-12
Start date
2023-05-04
Completion date
2024-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Sleep Disorder

Brief 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.

Interventions

DIAGNOSTIC_TESTpolysomnography

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years old; * arterial hypertension defined as: a) office systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg AND either 24-hour ambulatory systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg OR b) the presence of antihypertensive treatment; * non-dipper pattern at 24-hour BP monitoring (confirmed on repeated ABPM including one performed within 3 months prior to enrolment and one after enrolment, both on the same antihypertensive treatment, if any), defined as a nocturnal decrease systolic and/or in diastolic BP values \<10% compared to the corresponding daytime values; * signed written informed consent;

Exclusion criteria

* shift workers * atrial fibrillation/flutter; * pregnancy and lactation; * terminal malignant disease, life expectancy \<6 months; * limb amputation; * dementia.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of sleep disordersbaselinePhenotype patients with non-dipper status with or without nocturnal hypertension in order to establish the prevalence of sleep disturbances such as sleep apnea syndrome, insomnia and restless legs syndrome

Countries

Italy

Contacts

Primary ContactMartino Pengo, MD, PhD
m.pengo@auxologico.it00390261911
Backup ContactElisa Nardin, RN
intodip@auxologico.it00390261911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026