Sleep Quality Underwent Heart Transplant, an Observational Study (SQ_Heart)

December 3, 2020 updated by: University of Padova

Sleep Quality: Comparison Between Patients With VAD and Patients That 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality Index
Time Frame: up 30 days
sleep quality
up 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQ_Heart2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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