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A Pilot, Multi-Center, Open-Label, Parallel Group Study to Assess the Effects of a Novel Application of Non-Invasive Positive Pressure Ventilation(NPPV) therapy for COPD patients with comorbid Sleep-Disordered Breathing

A Pilot, Multi-Center, Open-Label, Parallel Group Study to Assess the Effects of a Novel Application of Non-Invasive Positive Pressure Ventilation(NPPV) therapy for COPD patients with comorbid Sleep-Disordered Breathing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012648
Enrollment
Unknown
Registered
2017-09-12
Start date
2017-09-20
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease and obstructive sleep apnea overlap syndrome

Interventions

BiPAP S/T group:BiPAP S/T
BiPAP AVAPS-AE group:BiPAP AVAPS-AE

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Stage I 1. All hospitalized patients who meet the COPD diagnostic creteria; 2. Less than 24 hours after admission; 3. Agree to paticipant in this study. Stage II: 1. To be diagnosed with Overlap syndrome and AHI=15/h; 2. To be diagnosed with COPD by Pulmonary Function Tests within half a year; 3. Need NPPV treatment regarding to clinical judgements (Conscious,RR>25/min,7.2545mmHg); 4. Strong airway protection ability; 5. Without head and facial imjuries; 6. Only adults>30kg. Stage III: 1. Hospitalized due to AECOPD; 2. PH=7.35, PaCO2>45mmHg during admission (Quiescent condition, Air); 3. PH>7.35, PaCO2>45mmHg when discharged(Quiescent condition, Air); 4. Treated with NPPV during hospitalization with good compliance; 5. BMI30kg.

Exclusion criteria

Exclusion criteria: Stage I: 1. Patient who refuse to participate in this study. Stage II: 1. Type II respiratory faliure that is caused by COPD; 2. Complicated with pulmonary disease but COPD; 3. BMI>35kg/m2; 4. Infectious diseases(such as Pulmonary Tuberculosis,etc); 5. Quit during study; 6. Death during study. Stage III: 1. Type II respirotery failure that is not caused by COPD; 2. Complicated with pulmonaty diseases but COPD; 3. Poor compliance duting hospital NPPV treatment; 4. Infectious diseases(such as Pulmonary Tuberculosis,etc); 5. Need long-term Glucocorticoid therapy(not including inhealed corticosteroids); 6. Co-morbid with other complication and Predictive survival timme is less than 1 year; 7. Already under home BiPAP treatment; 8. Quit during study.

Design outcomes

Primary

MeasureTime frame
PSQI;Pulmonary function test;AHI;blood gas analysis;NPPV treatment duration when in hospital;SACS;

Secondary

MeasureTime frame
mMRC;CAT;mEpworth;Acute exacerbation COPD of the interval and duration;

Countries

China

Contacts

Public ContactJinnong Zhang

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

zjnwhhb@163.com+86 15972021289

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026