Last reviewed · How we verify
NCT06302738: INTO-DIP
Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern
trial testing polysomnography in Hypertension in 143 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Istituto Auxologico Italiano |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 143 |
| Start date | 4 May 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 11 locations across Italy |
Drugs / interventions tested
- polysomnography
Conditions studied
- Hypertension — all drugs for Hypertension →
- Sleep Disorder — all drugs for Sleep Disorder →
Sponsor
Istituto Auxologico Italiano — full company profile →
Who can join
18 and older, any sex, with Hypertension or Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06302738
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of polysomnography
Trials testing the same drug.
- NCT07356908 — Impact of Sleep Related Breathing Disorders on Outcomes of Acute Pulmonary Embolism · completed
- NCT05391945 — Effects of Thyroidectomy on Obstructive Sleep Apnea in Patients Suffering From Goiters · recruiting
- NCT05868694 — A Study of Breathing Sound-based Classification of Patients With Breathing Disorders · unknown
- NCT05136001 — Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmon · completed
- NCT05057975 — Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis · NA · completed
Other recruiting trials for Hypertension
Currently open trials in the same condition.
- NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
- NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Istituto Auxologico Italiano trials
Trials by the same sponsor.
- NCT07384962 — ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery · not yet recruiting
- NCT07358832 — Neuromodulation Through Multisensory Stimulation for Visual Field Deficits in the Subacute Stage of Disease · NA · recruiting
- NCT07302321 — Needs of ALS Patients With C9orf72 Mutation and Their Caregivers · recruiting
- NCT07162740 — Implantable Loop Recorder and Cardioneuroblation · not yet recruiting
- NCT07312240 — LONgitudinal and Integrated Evaluation of Biomarkers in reLation to phenotYpe in ALS · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06302738 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Auxologico Italiano
- Last refreshed: 16 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06302738.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing