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SQ_Heart: Sleep Quality Underwent Heart Transplant, an Observational Study

Sponsor
University of Padova (Other)
Overall Status
Completed
CT.gov ID
NCT03281525
Collaborator
(none)
176
Enrollment
1
Location
5.7
Actual Duration (Months)
31.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    176 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study
    Actual Study Start Date :
    Apr 11, 2017
    Actual Primary Completion Date :
    Sep 30, 2017
    Actual Study Completion Date :
    Sep 30, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Sleep Quality Index [up 30 days]

      sleep quality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera di Padova Padova Italy 35128

    Sponsors and Collaborators

    • University of Padova

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Padova
    ClinicalTrials.gov Identifier:
    NCT03281525
    Other Study ID Numbers:
    • SQ_Heart2017
    First Posted:
    Sep 13, 2017
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Padova
    cardiotransplant
    Additional relevant MeSH terms:
    Ventricular Dysfunction

    Study Results

    No Results Posted as of Dec 4, 2020