Skip to main content
OpenTrials
Completed

NCT Number: NCT03281525

Sleep Quality Underwent Heart Transplant, an Observational Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera di Padova

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sleep Quality Index

    Time frame: up 30 days

    sleep quality

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: SQ_Heart

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2017
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.