Noninvasive Positive Pressure Ventilation in Overlap Syndrome

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03184714
• Collaborator: (none)
• Enrollment: 292
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42.5
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Sleep Apnea Syndromes; Non-invasive Positive Pressure Ventilation	Device: NIPPV	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 292 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: non-invasive positive pressure ventilationnon-invasive positive pressure ventilation
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome
• Anticipated Study Start Date: Jun 15, 2017
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Experimental: Interventional group NIPPV as treatment of OS	Device: NIPPV; BiPAP treatment for 3 years

Outcome Measures

Primary Outcome Measures

1. COPD acute exacerbations [3 years]

   total times of COPD acute exacerbations

Secondary Outcome Measures

1. COPD assessment test (CAT) score [3 years]

   symptom score of COPD

2. modified British medical research council (mMRC) score [3 years]

   dyspnea score

3. all-cause mortality [3 years]

   survival rate in %

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianguo He, Chief of Pulmonary Vascular Disease Center, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT03184714
• Other Study ID Numbers: 2016YFC1304403B
• First Posted: Jun 14, 2017
• Last Update Posted: Jun 14, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Syndrome

Study Results

No Results Posted as of Jun 14, 2017