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

Phase 1

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00157183
• Lead Sponsor: Bayside Health

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)

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 Timeline

• Study Start: 2003-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale
Pittsburgh Sleep Quality Index
Quality of life questionnaires:
CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
Baseline Dyspnea Index, Transitional Dyspnea Index
Daytime arterial blood gases (PaCO2, PaO2)
CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
Medical Research Council Dyspnea Scale
Work or Study status
Physiological:
Nocturnal SpO2, nocturnal rise in transcutaneous CO2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Alfred; 🇦🇺 Melbourne, Victoria, Australia