Please select the eligibility criteria that correspond to the clinical trial below.
Title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Brief Summary: Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD, but no evidence exists about the effect of long term application/home application.

This study tests the hypothesis, that a daily, 6 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.


Options:
A: Inclusion Criteria:

* Moderate or severe COPD with insufficiency of the ventilatory pump (according to GOLD stage IV). Stable disease since four weeks or more prior to randomisation. The COPD might be caused by whatever reason (smoking, Alpha-1 antitrypsin deficiency, ....). Smokers can be included.
* Capillary PCO2 of 7 kPa (51,8 mmHg) or maximally 10 kPa (74 mmHg), combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position. Patients on long term oxygen treatment must inhale oxygen in their prescribed dose.
* Only patients in the age of 18 years or above can be included.
* Written information about all aspects of the study (available in German language) must be provided for each patient. Written informed consent prior to any measure of this protocol is necessary for inclusion.

Exclusion Criteria:

* Patients with a PCO2 of 10 kPa (74 mmHg) or above. These patients can be re-evaluated for inclusion after 4 weeks.
* Diseases of the lung or thorax besides COPD: Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2.
* Patients on NIV.
* Body mass index of 35 kg/m² or above.
* Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion).
* Malignoma
* Disorders of the basal brain nerves with derangement of swallowing, or reflexes of swallowing and choking.
* Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
* Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study.
B: Inclusion Criteria:

* Patients with COPD
* Acute hypercapnic exacerbation of COPD at least 2 weeks previously
* Tolerated non-invasive ventilation during acute hypercapnic exacerbation
* Chronic hypoxia requiring LTOT (PaO2 \<7.3kPa or a PaO2 \>7.3 and \<8.0kPa and one of the following: secondary polycythaemia; nocturnal hypoxaemia SaO2 \<90% for \>30% of the time; peripheral oedema; or PHT)
* Chronic hypercapnia (PaCO2 \>7kPa)
* ≥20 pack year smoking history
* FEV1/FVC \<60%
* FEV1 at \<50% predicted

Exclusion Criteria:

* Persistent hypercapnic respiratory failure with acidosis (defined as pH \<7.30 after bronchodilators)
* Development of worsening hypercapnic respiratory failure with acidosis during initiation of LTOT therapy
* Failure to tolerate NIV during the acute illness preceding trial identification
* Post extubation or decannulation following AHRF requiring intubation
* Restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the FEV1/FVC ratio is \<60% and the FEV1 \<50% if the predominant defect is considered to be obstructive by the center clinician.
* Clinical features of severe OSA
* BMI \>35kg/m2
* Unstable coronary artery syndrome
* Cognitive impairment that would prevent informed consent into the trial
* Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
* Patients undergoing renal replacement therapy
* Age \<18 years
* Pregnant
* Inability to comply with the protocol
C: Inclusion Criteria

* Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30
* Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness
* Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry
* Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry
* Has access to a telephone

Exclusion Criteria

* Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy
* Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA
* Oxygen or bi-level CPAP required for treatment of OSA
* Unable to return for study instructions or follow-up testing
* Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry
* Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry
* Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry
* History of automobile accidents due to excessive daytime sleepiness
* Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
* Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry
* Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent)
* Recent or recurring history of substance abuse leading to tolerance or dependence
* Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test
* Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury)
* Residing with an individual who is currently using CPAP treatment
D: Inclusion Criteria:

* clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

Exclusion Criteria:

* thorax or the lung other than COPD
* No smoking or Cigarette≤10/day
* obesity with a bodymass index (BMI) ≥40 kg/m²
* malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

Answer: A