Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients

NCT03651492 | Unknown

• 1 other identifier: FedericoIIUniversity
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Nocturnal hypertension (i.e. blood pressure values \>120/70 or 10% higher than diurnal values, as measured by ambulatory blood pressure monitoring, ABPM) is particularly frequent in renal transplant recipients (RTR), despite the use of antihypertensive drugs. Since RTR are also affected by several sleep disorders (like insomnia, restless legs syndrome, sleep apnoea) that frankly impair their quality of sleep (SQ), the aim of the present study is to ascertain whether a relationship exists between nocturnal hypertension and SQ. In fact, both nocturnal hypertension and sleep disorders may favour the onset or the progression of cardiovascular diseases, the first cause of death in RTR.

Conditions

Hypertension; Nephropathy; Renal Transplant; Sleep Disorder

Keywords

nocturnal hypertension; renal transplantation; sleep quality

Outcome Measures

Primary Outcomes (1)

• Prevalence of "poor sleepers", as assessed by Pittsburgh Questionnaire, among renal transplant recipients with elevated blood pressure, measured by ambulatory continuous monitoring.

  Sleep quality will be evaluated by the Pittsburgh Questionnaire, which allows to investigate on 7 different components of sleep, determining a score ranging between 0 and 19: a score\>5 defines a "poor sleeper". Through bivariate and multivariate analysis, the study will evaluate which relationship exists between nocturnal hypertension ands sleep quality.

  Given the cross-sectional nature of the study, there is a single determination of sleep quality in each patient, carried out after completion of 24-hour ABPM, during a scheduled follow-up visit.

Interventions

questionnaire administration BEHAVIORAL

All the patients will be administered the Pittsburgh Questionnaire after completion of ABPM.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with functioning renal transplantation in regular follow-up at DH of renal transplantation of the University Federico II of Naples (Italy)

You may qualify if:

• Age\>18 years
• Transplant vintage \>1 year;
• Stable renal function in the last 6 months;
• No change in antihypertensive and immunosuppressive therapy in the last 3 months;
• No rejection episode in the last 6 months.

You may not qualify if:

• Intercurrent infections in the last 3 months;
• Treatment with sleeping or antidepressant pills;
• Patients with neurological problems in treatment with drugs acting on central nervous system;
• Patients unable to understand the meaning of the questions.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Hypertensive Nephropathy; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Massimo Sabbatini, PhD

CONTACT

+39081 746 2614; sabbatin@unina.it

Oto Di Gruttola, MD

CONTACT

+39 081 746 2151; otodi88@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nephrology

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 29, 2018
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: January 31, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)