Sleep Quality Underwent Heart Transplant, an Observational Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281525

Acronym

SQ_Heart

Enrollment

176

Registered

2017-09-13

Start date

2017-04-11

Completion date

2017-09-30

Last updated

2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Dysfunction

Keywords

cardiotransplant

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sleep Quality Index	up 30 days	sleep quality

Countries

Italy

Outcome results