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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000420640

Enrollment

Registered

2005-09-16

Start date

1998-06-11

Completion date

2010-04-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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

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 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'

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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.

Outcome results