NCT04957004

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

June 29, 2021

Last Update Submit

July 4, 2021

Conditions

Keywords

OSACPAPleft ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    The follow-up period was 1 year

Study Arms (2)

OSA patients

Patients with OSA who have not been treated with CPAP

Device: CPAP

control group

health control except OSA by using sleep monitorin

Interventions

CPAPDEVICE

CPAP ventilator was worn at nigh

OSA patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • poor image quality of echocardiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Yongzhen Zhang

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 9, 2021

Study Start

July 22, 2018

Primary Completion

December 22, 2019

Study Completion

June 30, 2020

Last Updated

July 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations