Ventricular DysfunctionSQ_HeartNCT03281525
Sleep Quality Underwent Heart Transplant, an Observational Study
An observational study of Ventricular Dysfunction, run by University of Padova at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Dysfunction
- How many people
- 176 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2017to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD
Who may be able to join
- Age ≥ 18 and < 90;
- Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
- patients with VAD ;
- subjects able to sign informed consent.
Who cannot join
- Age < 18;
- subjects don't sign informed consent;
- hospitalization for more than 30 days before compilation in intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study
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.
- Conditions
- Ventricular Dysfunction
- Keywords
- cardiotransplant
- Medical subject headings
- Ventricular Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality Index
sleep quality
Measured: up 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start11 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281525
- Sponsor's protocol ID
- SQ_Heart2017
- Acronym
- SQ_Heart
- Status last verified
- Dec 2020
- First submitted
- 5 Sep 2017
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study
- ClinicalTrials.gov ID
- NCT03281525
- Acronym / sponsor ID
- SQ_Heart / SQ_Heart2017
- Conditions
- Ventricular Dysfunction
- Keywords
- cardiotransplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiotransplant patients with VAD (Ventricular Assisted Device) or non; Patients with VAD
Key inclusion criteria (4 listed)
- Age ≥ 18 and < 90;
- Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non;
- patients with VAD ;
- subjects able to sign informed consent.
Key exclusion criteria (3 listed)
- Age < 18;
- subjects don't sign informed consent;
- hospitalization for more than 30 days before compilation in intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep Quality Index
Time frame: up 30 days
sleep quality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Dysfunction, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality Index (time frame: up 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.