OSANCT04957004
Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D STE
An observational study of OSA and Left Ventricular Dysfunction, run by Peking University Third Hospital at 1 site in China.
Trial summary
The changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- OSA, Left Ventricular Dysfunction
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2018to 30 Jun 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with OSA who underwent sleep monitoring at the Sleep Medicine Center of Peking University Third Hospital were selected for the study.OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014.Exclusion criteria from this study included previously diagnosed patients with heart failure,coronary artery disease,valvular disease,cardiomyopathy,arrhythmia,chronic obstructive/ restrictive pulmonary disease, thyroid dysfunction (including hypothyroidism or hyperthyroidism), already treated with CPAP, and poor image quality of echocardiography. Healthy subjects who underwent sleep monitoring to exclude OSA were selected as the control group during the same period.
Who may be able to join
- OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014
- Between the ages of 18 and 80, regardless of gender
- Sign informed consent
Who cannot join
- previously diagnosed patients with heart failure,
- coronary artery disease,
- valvular disease,
- cardiomyopathy,
- arrhythmia,
- chronic obstructive/ restrictive pulmonary disease,
Show all 9Show fewer
- thyroid dysfunction (including hypothyroidism or hyperthyroidism),
- already treated with CPAP,
- poor image quality of echocardiography.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D Speckle-tracking Echocardiography
The changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment
Read the detailed description
Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate the impact and degree of OSA on left ventricular function.
(2) By comparing the changes in the three-dimensional ultrasound strain index of the left ventricle of patients before and after CPAP treatment, and in patients receiving and not receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement of cardiac function in patients with OSAS, and to infer the best suitable intervention population and using time, providing reference basis for clinical treatment.
(3) Discovery of serological indicators that predict the severity of the disease and predict the impairment of heart function Study design: This study is a prospective, observational controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the Peking University Third Hospital and a control group selected according to age and gender matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is measured by the 3D speckle tracking technology, and the serological indicators are detected. The OSAS group and the control group were followed up during the course of receiving or not receiving CPAP.
- Conditions
- OSA, Left Ventricular Dysfunction
- Being tested
- CPAP
- Keywords
- OSA, CPAP, left ventricular dysfunction
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP ventilator was worn at nigh
| Study group | Role | What they receive |
|---|---|---|
| OSA patients | Patients with OSA who have not been treated with CPAP Receives: Device: CPAP | |
| control group | health control except OSA by using sleep monitorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of echocardiographic and serological indexes were observed by 3D speckled tracking during the 1-year follow-up
The changes of echocardiographic indexs such as left ventricular three-dimensional strain and serological indexes including adiponectin.
Measured: The follow-up period was 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start22 Jul 2018
- Primary completion22 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongzhen Zhang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957004
- Sponsor's protocol ID
- M2017397
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D Speckle-tracking Echocardiography
- ClinicalTrials.gov ID
- NCT04957004
- Acronym / sponsor ID
- M2017397
- Conditions
- OSA, Left Ventricular Dysfunction
- Keywords
- OSA, CPAP, left ventricular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Jul 2018 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 9 Jul 2021 (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 changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment
Detailed description
Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate the impact and degree of OSA on left ventricular function.
(2) By comparing the changes in the three-dimensional ultrasound strain index of the left ventricle of patients before and after CPAP treatment, and in patients receiving and not receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement of cardiac function in patients with OSAS, and to infer the best suitable intervention population and using time, providing reference basis for clinical treatment.
(3) Discovery of serological indicators that predict the severity of the disease and predict the impairment of heart function Study design: This study is a prospective, observational controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the Peking University Third Hospital and a control group selected according to age and gender matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is measured by the 3D speckle tracking technology, and the serological indicators are detected. The OSAS group and the control group were followed up during the course of receiving or not receiving CPAP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA patients | – | Device: CPAPPatients with OSA who have not been treated with CPAP |
| control group | – | –health control except OSA by using sleep monitorin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OSA who underwent sleep monitoring at the Sleep Medicine Center of Peking University Third Hospital were selected for the study.OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014.Exclusion criteria from this study included previously diagnosed patients with heart failure,coronary artery disease,valvular disease,cardiomyopathy,arrhythmia,chronic obstructive/ restrictive pulmonary disease, thyroid dysfunction (including hypothyroidism or hyperthyroidism), already treated with CPAP, and poor image quality of echocardiography. Healthy subjects who underwent sleep monitoring to exclude OSA were selected as the control group during the same period.
Key inclusion criteria (3 listed)
- OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014
- Between the ages of 18 and 80, regardless of gender
- Sign informed consent
Key exclusion criteria (9 listed)
- previously diagnosed patients with heart failure,
- coronary artery disease,
- valvular disease,
- cardiomyopathy,
- arrhythmia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP ventilator was worn at nigh | Device | OSA patients |
Primary outcome
The changes of echocardiographic and serological indexes were observed by 3D speckled tracking during the 1-year follow-up
Time frame: The follow-up period was 1 year
The changes of echocardiographic indexs such as left ventricular three-dimensional strain and serological indexes including adiponectin.
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 9 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Yongzhen Zhang principal investigator
Peking University Third Hospital
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 OSA and Left Ventricular Dysfunction, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 9 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 9 Jul 2021. 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 China. 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?
The changes of echocardiographic and serological indexes were observed by 3D speckled tracking during the 1-year follow-up (time frame: The follow-up period was 1 year). 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 9 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.