Noninvasive Positive Pressure Ventilation in Overlap Syndrome

June 10, 2017 updated by: Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital

The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome

Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is still not fully investigated. The aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Renmin Hospital Of Wuhan University
        • Contact:
          • Ke Hu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with COPD and sleep apnea dyspnea syndrome

Exclusion Criteria:

  • patients with non-stable hemodynamics;
  • patients with limited life expectancy;
  • patients with other severe respiratory diseases;
  • patients with motor neuron diseases;
  • patients with contraindications for NIPPV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Interventional group
NIPPV as treatment of OS
Device: NIPPV
BiPAP treatment for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD acute exacerbations
Time Frame: 3 years
total times of COPD acute exacerbations
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD assessment test (CAT) score
Time Frame: 3 years
symptom score of COPD
3 years
modified British medical research council (mMRC) score
Time Frame: 3 years
dyspnea score
3 years
all-cause mortality
Time Frame: 3 years
survival rate in %
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 10, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 10, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1304403B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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