Noninvasive Positive Pressure Ventilation in Overlap Syndrome

NCT03184714 — Not applicable, Unknown, 292 participants, Chinese Academy of Medical Sciences, Fuwai Hospital

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The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome

Registry	NCT03184714
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	292 (Estimated)
Sponsor	Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Conditions	COPD, Sleep Apnea Syndromes, Non-invasive Positive Pressure Ventilation
Interventions	NIPPV (Device)
Dates	start 2017-06-15 (estimated), primary completion 2020-12-31 (estimated), completion 2020-12-31 (estimated), first posted 2017-06-14, last updated 2017-06-14
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control	No intervention
Interventional group	Experimental	Device: NIPPV	NIPPV as treatment of OS

NIPPV (Device): BiPAP treatment for 3 years

+Outcome measures

Primary outcomes

COPD acute exacerbations [3 years]: total times of COPD acute exacerbations

Secondary outcomes

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

+Eligibility

Sex: All, ages: 40 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Renmin Hospital of Wuhan University	Wuhan, Hubei	China	Recruiting

My Notes

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