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CompletedPhase 3ACTRN12605000420640

Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis

Sponsor

SWSAHS

Enrollment

40 participants

Start Date

Jun 11, 1998

Study Type

Interventional

Conditions

Cystic Fibrosis

Summary

Last participant recruited 16/4/2010. Recruitment halted 2015 as no participant recruited in last 5 years. Data analysis ongoing.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Stable CF adults with total sleep time minimum average oxygen saturation <=90%

Exclusion Criteria1

  • Acute unstable hypercapnic respiratory failure (PaCO2>60; eligible for randomisation after acute treatment if stable off NIV for a minimum of two weeks); severe co-existing disease; persistent pneumothoraces; sputum colonised with burkolderia cepacia.

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Interventions

Patients will be randomised to oxygen alone or NIV with or without oxygen, as titrated during polysomnography to maintain oxygen saturation >=90% in all sleep stages. Patients will be followed-up over

Patients will be randomised to oxygen alone or NIV with or without oxygen, as titrated during polysomnography to maintain oxygen saturation >=90% in all sleep stages. Patients will be followed-up over 12 months. Repeat sleep studies at 3, 6 and 12 months. They will be censored if they undergo lung transplant or die. They cease the trial if defined as a 'treatment failure'

Locations(1)

Australia

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