Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients (NCT03651492) | Clinical Trial Compass
UnknownNot Applicable
Effects of Nocturnal Hypertension on Sleep Quality in Renal Transplant Recipients
Italy200 participantsStarted 2017-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of "poor sleepers", as assessed by Pittsburgh Questionnaire, among renal transplant recipients with elevated blood pressure, measured by ambulatory continuous monitoring.
Timeframe: 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.