Noninvasive Positive Pressure Ventilation in Overlap Syndrome

COPD Clinical Trial

Official title:

The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03184714
• Other study ID #: 2016YFC1304403B
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 10, 2017
• Start date: June 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Ke Hu, MD
• Phone: 18971035988
• Email: hukejx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 292
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Non-invasive Positive Pressure Ventilation
• Sleep Apnea Syndromes
• Syndrome

Intervention

Device:
• NIPPV
BiPAP treatment for 3 years

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD acute exacerbations	total times of COPD acute exacerbations	3 years
Secondary	COPD assessment test (CAT) score	symptom score of COPD	3 years
Secondary	modified British medical research council (mMRC) score	dyspnea score	3 years
Secondary	all-cause mortality	survival rate in %	3 years