Noninvasive Positive Pressure Ventilation in Overlap Syndrome

NCT ID: NCT03184714

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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COPD Sleep Apnea Syndromes Non-invasive Positive Pressure Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

non-invasive positive pressure ventilation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional group

NIPPV as treatment of OS

Group Type EXPERIMENTAL

NIPPV

Intervention Type DEVICE

BiPAP treatment for 3 years

Interventions

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NIPPV

BiPAP treatment for 3 years

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jianguo He

Chief of Pulmonary Vascular Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ke Hu, MD

Role: CONTACT

18971035988

Facility Contacts

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Ke Hu, MD

Role: primary

Other Identifiers

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2016YFC1304403B

Identifier Type: -

Identifier Source: org_study_id

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