Sleep Quality Underwent Heart Transplant, an Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-11

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Ventricular Dysfunction

Keywords

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cardiotransplant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

Countries

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Italy

Other Identifiers

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SQ_Heart2017

Identifier Type: -

Identifier Source: org_study_id