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NCT03281525 Clinical Trial

Sleep Quality Underwent Heart Transplant, an Observational Study

Ventricular Dysfunction Clinical Trial

— SQ_Heart  

Official title:
Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03281525
Other study ID # SQ_Heart2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 11, 2017
Est. completion date September 30, 2017

Study information
Verified date December 2020
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The SQ_Heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98 Cardiotransplant patients.

Description:

The Primary objective of the SQ_Heart study is to evaluate the significant difference in sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of > 5 for poor sleepers. Patients, to be enrolled, must provide: - Age ≥ 18 and < 90; - Cardiotransplant patients, with VAD or non; - patients with VAD. - subjects able to sign informed consent. All the patients will have to complete some questionnaires: - questionnaire about the diagnosis of pathology and lifestyle; - questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep Quality (PSQI); - questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L). Questionnaires are necessary for the data collection for the study.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age = 18 and < 90; - Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non; - patients with VAD ; - subjects able to sign informed consent. Exclusion Criteria: - Age < 18; - subjects don't sign informed consent; - hospitalization for more than 30 days before compilation in intensive care unit.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Azienda Ospedaliera di Padova Padova

Sponsors (1)
Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Quality Index sleep quality up 30 days
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