CompletedNCT00914264Updated Jul 18, 2018

The Effects of Continuous Positive Airway Pressure on Overlap Syndrome

An observational study in COPD & OSA, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 90
Ages: 18 Years and older
Sex: All

Study summary

The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance.
The second objective of this study is to evaluate the subacute (3 months treatment) CPAP effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, We will also determine the subacute effect of CPAP on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance.
The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. The long term CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.

Read the detailed description

COPD patients will be disturbed by season 12 months follow up is better than 18 months

Conditions studied

COPD & OSA

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Keywords

chronic obstructive airway disease
obstructive sleep apnea
continuous positive airway pressure

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 90 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 238 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

from outpatient clinic of CGMH and those in COPD cohort

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

chronic stable COPD
FEV1/FVC \< 70%
No response to beta-agonist
without acute exacerbation within2 months

Exclusion criteria

Exclusion Criteria:

Chronic respiratory failure (PaO2\<60 mmHg, PaCO2>50 mmHg)
Clinical evidence of congestive heart failure
Facial defect and all the other condition that can't tolerate nasal mask
Malignancy

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 90 participants (estimated)

Groups and cohorts

COPD with OSA with CPAP treatment
COPD with OSA: CPAP treatment
Device: continuous positive airway pressure
COPD without OSA
COPD without OSA, not treat with CPAP
COPD with OSA but without CPAP treatment
COPD with OSA but patient refused CPAP treatment

Interventions

Devicecontinuous positive airway pressure
CPAP with adequate pressure for 1 day, 3 \& 12 months

What researchers measure

Primary outcomes

exercise performance
the condition of COPD patient will be disturbed by season factor 12 months follow up will be better than 18 months
Time frame: 3 days, 3 & 12 months

Secondary outcomes

autonomic nerve activity
the same reason as above
Time frame: 3 days, 3 & 12 months
mortality and acute exacerbation
Time frame: 1, 5, 10 years

Study locations

1 site

Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 105, Taiwan

References and documents

Publications

Wang TY, Lo YL, Lee KY, Liu WT, Lin SM, Lin TY, Ni YL, Wang CY, Ho SC, Kuo HP. Nocturnal CPAP improves walking capacity in COPD patients with obstructive sleep apnoea. Respir Res. 2013 Jun 19;14(1):66. doi: 10.1186/1465-9921-14-66. PubMed 23782492 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2008, a primary completion of Nov 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 2, 2009
First posted: Jun 4, 2009
Start: Dec 2008
Primary completionActual: Nov 2016
CompletionActual: Dec 2016
Last update: Jul 18, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00914264
Lead sponsor: Chang Gung Memorial Hospital
Responsible party: Sponsor
First posted: Jun 4, 2009
Start date: Dec 2008
Primary completion: Nov 2016
Completion: Dec 2016
Last update: Jul 18, 2018

Study contacts

Yu-Lun Lo, MD

study director · Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Tsai-Yu Wang, MD

principal investigator · Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Han-Pin Kuo, MD,PHD

study chair · Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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