ClinicalTrials.gg
CompletedNCT03281525SQ_HeartUpdated Dec 4, 2020

Sleep Quality Underwent Heart Transplant, an Observational Study

An observational study in Ventricular Dysfunction, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-04.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
176
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventricular Dysfunction

Keywords

  • cardiotransplant
03

In context

Ventricular Dysfunction

85 studies on the registry are indexed under Ventricular Dysfunction; 11 are open to participants now.

This study's enrollment of 176 is above the median of 140 across 34 observational studies indexed under Ventricular Dysfunction.

Browse Ventricular Dysfunction studies →

Lead sponsor

University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 and \< 90;
  • Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
  • patients with VAD ;
  • subjects able to sign .

Exclusion criteria

Exclusion Criteria:

  • Age \< 18;
  • subjects don't sign ;
  • hospitalization for more than 30 days before compilation in intensive care unit.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
176 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Sleep Quality Index

    sleep quality

    Time frame: up 30 days

07

Study locations

1 site
  • Azienda Ospedaliera di Padova
    Padova, 35128, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Sep 2017, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 13, 2017
StartActual
Apr 11, 2017
Primary completionActual
Sep 30, 2017
CompletionActual
Sep 30, 2017
Last update
Dec 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03281525
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Apr 11, 2017
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017
Last update
Dec 4, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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