Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

This study has been completed.
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Australia
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00157183
First received: September 9, 2005
Last updated: December 4, 2013
Last verified: September 2005

September 9, 2005
December 4, 2013
March 2003
March 2006   (final data collection date for primary outcome measure)
  • Quality of life questionnaires:
  • CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
  • Epworth Sleepiness Scale
  • Pittsburgh Sleep Quality Index
  • CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
  • Medical Research Council Dyspnea Scale
  • Baseline Dyspnea Index, Transitional Dyspnea Index
  • Work or Study status
  • Physiological:
  • Nocturnal SpO2, nocturnal rise in transcutaneous CO2
  • Daytime arterial blood gases (PaCO2, PaO2)
Same as current
Complete list of historical versions of study NCT00157183 on ClinicalTrials.gov Archive Site
  • Admission rate
  • Lung function tests (FEV1, FVC, RV/ TLC)
  • Modified CF shuttle walk test
  • Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)
  • PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)
  • Serum cytokines (IL-6, TNF alpha, IL-1 beta)
Same as current
Not Provided
Not Provided
 
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

The purpose of this study is to determine whether correction of low nighttime oxygen (O2) levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which assists breathing (non-invasive positive pressure ventilation, NIPPV)

Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population with a median survival of 31 years. Lung disease is responsible for the majority of morbidity and mortality and correlates with declining quality of life. Respiratory failure is the primary cause of death. Daytime respiratory failure (hypoxia with pO2<55 and/or hypercapnia with pCO2>50) is associated with a worse prognosis with a 2-year survival of 50%. Nocturnal respiratory failure (greater than 5% of the night spent with SpO2<90% and/or rise in PtcCO2>10mmHg overnight) is a precursor to the development of daytime respiratory failure. It has been postulated that earlier treatment of respiratory failure may improve outcome and quality of life.

Intervention: Nocturnal O2 and bilevel NIPPV in CF patients with nocturnal respiratory failure, compared to nocturnal placebo (air). Crossover trial utilising patients as their own control.

Aims: (1) To assess the effects of non-invasive ventilation (NIV) and oxygen (O2) therapy on quality of life, hospital admission rate, sleep quality and exercise tolerance in CF patients with NRF (2) To identify a level of severity of NRF where treatment with NIV is effective

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Cystic Fibrosis
Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation
Not Provided
Young AC, Wilson JW, Kotsimbos TC, Naughton MT. The impact of nocturnal oxygen desaturation on quality of life in cystic fibrosis. J Cyst Fibros. 2011 Mar;10(2):100-6. doi: 10.1016/j.jcf.2010.11.001. Epub 2010 Dec 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

proven diagnosis cystic fibrosis, age 18 years or older, FEV1< 70% predicted normal, clinically stable (no admission or antibiotics last 2 weeks, OR end of admission where further clinical improvement not expected), nocturnal respiratory failure (SpO2<90% for > 10% of night or rise in PtcCO2 > 5 mmHg in REM), daytime hypercapnia (PaCO2> 45 mmHg)

Exclusion Criteria:

Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00157183
35/03
Not Provided
Bayside Health
Bayside Health
  • National Health and Medical Research Council, Australia
  • Monash University
  • Cystic Fibrosis Australia
Principal Investigator: Matthew T Naughton, MD The Alfred Hospital
Bayside Health
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP