Noninvasive Positive Pressure Ventilation in Overlap Synd... | NCT03184714

Studies
Noninvasive Positive Pressure Ventilation in Overlap Syndrome

NCT03184714

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Jun 14, 2017Actual

Enrollment

292Estimated

Phase

Not Applicable

Conditions

COPD
Sleep Apnea Syndromes
Non-invasive Positive Pressure Ventilation

Interventions

NIPPV

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jun 8, 2017

First Submission Date that Met QC Criteria

Jun 10, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2017

Last Update Posted Date

Jun 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

292Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Interventional group	Experimental	NIPPV as treatment of OS	Device: NIPPV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIPPV	Device	BiPAP treatment for 3 years	Interventional group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
COPD assessment test (CAT) score	symptom score of COPD	3 years
modified British medical research council (mMRC) score	dyspnea score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ke Hu, MD	Contact	18971035988		hukejx@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renmin Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided