Sleep Quality Underwent Heart Transplant, an Observational Study

Completed

• Conditions: Ventricular Dysfunction

• Registration Number: NCT03281525
• Lead Sponsor: University of Padova

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Quality Index	up 30 days	sleep quality

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy