CompletedPhase 1/2

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

Australia59 participantsStarted 2003-03

Plain-language 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)

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Trial details

NCT IDNCT00157183

SponsorBayside Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2006-03

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