None listed
Conditions
Interventions
A comparison of non-invasive nasal ventilation (NIV) during sleep plus long term oxygen therapy (LTOT) versus LTOT alone. The trial takes place over 2 years. In the intervention group, NIV is administered continuously during sleep every night during the trial.
Sponsors
Professor RD McEvoy MD, MBBS
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 80 Years
Healthy volunteers
No
Inclusion criteria
Chronic Airflow Limitation (FEV1< 1.5 or < 50% Predicted; FEV1/FVC < 60%, TLC > 92%; FEV1 with bronchodilators < 20%)+Daytime awake PaCO2 >46 mm Hg at least twice in the previous 6 months during periods of clinical stability;+Willing and competent to sign informed consent.+Under 80 years of age+On oxygen therapy for a minimum of three months prior to enrollment.
Exclusion criteria
Serious coexisting disease (eg. left ventricular failure, malignancy, renal failure, unstable angina) likely to affect survival during the study period+Significant Obstructive Sleep Apnea (defined as Apnoea/hypopoea index >20/h) or Obesity Hypoventilation Syndrome +Significant recent psychological or psychiatric problems likely to significantly impair ability to participate in the study and comply with treatment; +Previous treatment with NIV.
Outcome results
None listed