Non-invasive Ventilation and Oxygen Therapy in Cystic Fib... | NCT00157183

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

NCT00157183

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Dec 5, 2013Estimated

Enrollment

59Actual

Phase

Phase 1Phase 2

Conditions

Cystic Fibrosis

Interventions

Nocturnal oxygen , nocturnal bi-level positive pressure ventilation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 10, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Bayside HealthOTHER_GOV

Collaborators

Name	Class
National Health and Medical Research Council, Australia	OTHER
Monash University	OTHER
Cystic Fibrosis Federation Australia	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Name	Type	Description	Arm Group Labels	Other Names
Nocturnal oxygen , nocturnal bi-level positive pressure ventilation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Measure	Description	Time Frame
Admission rate
Lung function tests (FEV1, FVC, RV/ TLC)
Modified CF shuttle walk test

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew T Naughton, MD	The Alfred	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Alfred		Melbourne	Victoria	3181	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21195036	Derived	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.

ID	Term
D003550	Cystic Fibrosis
D000860	Hypoxia

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases