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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
59
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00157183