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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00157183




Registration number
NCT00157183
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
5/12/2013

Titles & IDs
Public title
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Scientific title
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Secondary ID [1] 0 0
35/03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nocturnal oxygen , nocturnal bi-level positive pressure ventilation

Treatment: Devices: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of life questionnaires:
Timepoint [1] 0 0
Primary outcome [2] 0 0
CFQoL questionnaire (Gee,Thorax,2000)(a priori chest, physical function, treatment, emotion domains)
Timepoint [2] 0 0
Primary outcome [3] 0 0
Epworth Sleepiness Scale
Timepoint [3] 0 0
Primary outcome [4] 0 0
Pittsburgh Sleep Quality Index
Timepoint [4] 0 0
Primary outcome [5] 0 0
CF Subjective Symptoms Sleep disturbance Questionnaire (CSQ-in house)
Timepoint [5] 0 0
Primary outcome [6] 0 0
Medical Research Council Dyspnea Scale
Timepoint [6] 0 0
Primary outcome [7] 0 0
Baseline Dyspnea Index, Transitional Dyspnea Index
Timepoint [7] 0 0
Primary outcome [8] 0 0
Work or Study status
Timepoint [8] 0 0
Primary outcome [9] 0 0
Physiological:
Timepoint [9] 0 0
Primary outcome [10] 0 0
Nocturnal SpO2, nocturnal rise in transcutaneous CO2
Timepoint [10] 0 0
Primary outcome [11] 0 0
Daytime arterial blood gases (PaCO2, PaO2)
Timepoint [11] 0 0
Secondary outcome [1] 0 0
Admission rate
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Lung function tests (FEV1, FVC, RV/ TLC)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Modified CF shuttle walk test
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Serum cytokines (IL-6, TNF alpha, IL-1 beta)
Timepoint [6] 0 0

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological
disease likely to compromise ventilatory control

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cystic Fibrosis Federation Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT00157183
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew T Naughton, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications