NCT03184714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

June 8, 2017

Last Update Submit

June 10, 2017

Conditions

COPDSleep Apnea SyndromesNon-invasive Positive Pressure Ventilation

Outcome Measures

Primary Outcomes (1)

  • COPD acute exacerbations

    total times of COPD acute exacerbations

    3 years

Secondary Outcomes (3)

  • COPD assessment test (CAT) score

    3 years

  • modified British medical research council (mMRC) score

    3 years

  • all-cause mortality

    3 years

Study Arms (2)

Control

NO INTERVENTION

Interventional group

EXPERIMENTAL

NIPPV as treatment of OS

Device: NIPPV

Interventions

NIPPVDEVICE

BiPAP treatment for 3 years

Interventional group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with COPD and sleep apnea dyspnea syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Ke Hu, MD

CONTACT

18971035988hukejx@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non-invasive positive pressure ventilation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Pulmonary Vascular Disease Center

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 14, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

CN(1)