NCT00157183

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 5, 2013

Status Verified

September 1, 2005

Enrollment Period

3 years

First QC Date

September 9, 2005

Last Update Submit

December 4, 2013

Conditions

Cystic Fibrosis

Keywords

cystic fibrosishypoxiaoxygennoninvasive ventilationquality of life

Outcome Measures

Primary Outcomes (11)

  • 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 (6)

  • Admission rate

  • Lung function tests (FEV1, FVC, RV/ TLC)

  • Modified CF shuttle walk test

  • Neurocognitive testing (psychomotor vigilance task, Stroop, Controlled Oral Word Association Test, Trails A and B, digit recall forwards backwards)

  • PSG (sleep efficiency, arousal index, % REM sleep, urinary catecholamines)

  • +1 more secondary outcomes

Interventions

Nocturnal oxygen , nocturnal bi-level positive pressure ventilationDEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Previous home O2 or NIV use, Sedative medications, Cardiac/renal/endocrine/neurological disease likely to compromise ventilatory control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred

Melbourne, Victoria, 3181, Australia

Location

Related Publications (1)

  • 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.

    PMID: 21195036DERIVED

MeSH Terms

Conditions

Cystic FibrosisHypoxia

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew T Naughton, MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

December 5, 2013

Record last verified: 2005-09

Locations

AU(1)