Please select the eligibility criteria that correspond to the clinical trial below.
Title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?
Brief Summary: The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic 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:

* Patient admitted with a NIV-requiring exacerbation of COPD
* COPD with a FEV1/FVC \<0.7 after bronchodilatation.
* ≥ 1 acute hypercapnic respiratory failure (AHRF \*).
* Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist Tiotropium, according to GOLD guidelines.
* Address in Capital Region
* Patients are able to give verbal consent and sign a written consent form and understand Danish-

Exclusion Criteria:

* Severely depressed level of consciousness / confusion / non-cooperative.
* Respiratory rate \<12/min
* Severe hypoxia, such as requiring more than 15L O2/min.
* Large amounts of sputum.
* Vomiting and high risk for aspiration.
* Inability to accept NIV.
* Recent abdominal, facial or upper airway surgery.
* Malignancy or life expectancy \<6 months because of disease other than COPD
* Known obstructive sleep apnea syndrome (OSA)
* Metabolic acidotic component - StHCO3- \< 20 mM
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:

* COPD (FEV1\< 50%, Tiffeneau \< 70%)
* Dyspnoea on exertion and a reduced exercise capacity
* Age 75 years or less
* PaCO2 \> 6.0 kPa at rest without oxygen

Exclusion Criteria:

* Cardial/neuromuscular diseases limiting a successful rehabilitation
* Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) \> 10
* Previous exposure to chronic NIPPV
* Participation in a pulmonary rehabilitation program less than 18 months ago

Answer: D