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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281525
Recruitment Status : Unknown
Verified September 2017 by University of Padova.
Recruitment status was:  Recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Padova

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
Ventricular Dysfunction

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.

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Study Type : Observational
Estimated Enrollment : 109 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 : April 11, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : September 30, 2017



Primary Outcome Measures :
  1. Sleep Quality Index [ Time Frame: up 30 days ]
    sleep quality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281525


Contacts
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Contact: Dario Gregori, PhD +390498275384 gredar@msn.it

Locations
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Italy
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: Gino Gerosa    0498212435      
Sponsors and Collaborators
University of Padova
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT03281525    
Other Study ID Numbers: SQ_Heart2017
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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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:
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Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases