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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 Federation 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
History of Changes
  Purpose
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)

Condition Intervention Phase
Cystic Fibrosis
 Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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)
Enrollment: 59
Study Start Date: March 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157183

Locations
Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
National Health and Medical Research Council, Australia
Monash University
Cystic Fibrosis Federation Australia
Investigators
Principal Investigator: Matthew T Naughton, MD The Alfred
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00157183     History of Changes
Other Study ID Numbers: 35/03 
Study First Received: September 9, 2005
Last Updated: December 4, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
cystic fibrosis
hypoxia
oxygen
noninvasive ventilation
quality of life

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 29, 2016