NCT03281525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

September 5, 2017

Last Update Submit

December 3, 2020

Conditions

Ventricular Dysfunction

Keywords

cardiotransplant

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality Index

    sleep quality

    up 30 days

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age \< 18;
  • subjects don't sign informed consent;
  • hospitalization for more than 30 days before compilation in intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Ventricular Dysfunction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 13, 2017

Study Start

April 11, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

December 4, 2020

Record last verified: 2020-12

Locations

IT(1)