Noninvasive Positive Pressure Ventilation in Overlap Syndrome

Not Applicable

• Conditions: COPD; Sleep Apnea Syndromes; Non-invasive Positive Pressure Ventilation
• Interventions: Device: NIPPV

• Registration Number: NCT03184714
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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 available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-10
• Last Update Submitted: 2017-06-10
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Study Start: 2017-06-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	NIPPV	NIPPV as treatment of OS

Primary Outcome Measures

Name	Time	Method
COPD acute exacerbations	3 years	total times of COPD acute exacerbations

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	3 years	survival rate in %
modified British medical research council (mMRC) score	3 years	dyspnea score
COPD assessment test (CAT) score	3 years	symptom score of COPD

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China