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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cystic Fibrosis	Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation	Phase 1; Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	59 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single
Primary Purpose:	Treatment
Official Title:	Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Study Start Date :	March 2003
Actual Primary Completion Date :	March 2006
Actual Study Completion Date :	March 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Quality of life questionnaires:
2. CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
3. Epworth Sleepiness Scale
4. Pittsburgh Sleep Quality Index
5. CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
6. Medical Research Council Dyspnea Scale
7. Baseline Dyspnea Index, Transitional Dyspnea Index
8. Work or Study status
9. Physiological:
10. Nocturnal SpO2, nocturnal rise in transcutaneous CO2
11. Daytime arterial blood gases (PaCO2, PaO2)

Secondary Outcome Measures :

1. Admission rate
2. Lung function tests (FEV1, FVC, RV/ TLC)
3. Modified CF shuttle walk test
4. Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)
5. PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)
6. Serum cytokines (IL-6, TNF alpha, IL-1 beta)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

Responsible Party:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00157183 History of Changes
Other Study ID Numbers:	35/03
First Posted:	September 12, 2005
Last Update Posted:	December 5, 2013
Last Verified:	September 2005

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