None listed
Conditions
Brief summary
Given the potential therapeutic effects of nocturnal hypoxaemia, this randomised controlled feasibility trial aims to examine the impacts of nocturnal oxygen versus medical air via stationary oxygen concentrator on health outcomes in people with fibrotic intersitial lung disease. This trial will be the first sham-controlled trial to examine effects of nocturnal oxygen therapy in fibrotic ntersitial lung disease.
Interventions
Nocturnal supplemental oxygen at a flow rate of 5 L/min via nasal cannula whilst asleep for 2 months. This will be delivered using a oxygen concentrator with telemonitoring for collection of usage data.
Sponsors
Yet Hong Khor - Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of 18 years and above 2. Able to give written informed consent 3. A multidisciplinary diagnosis of fibrotic interstitial lung disease of any aetiology 4. Suspected or previously known nocturnal hypoxaemia 5. Stable health condition (defined as no hospitalisation for acute medical condition) in the last 4 weeks before screening
Exclusion criteria
1. Use of or eligible for long-term oxygen therapy (defined as daytime resting SpO2 less than or equal to 88% or daytime resting PaO2 less than or equal to 55 mmHg or PaO2 56-59 mmHg with evidence of hypoxic organ damage [including right heart failure, pulmonary hypertension or polycythaemia]) 2. High risk of potential impacts of untreated obstructive sleep apnoea: public transport and truck drivers, heavy machinery workers, those with Epworth Sleepiness Scale of > 17 at the time of screening, and those with a history of motor vehicle accidents in the last 2 years 3. Established treatment with CPAP for OSA
Outcome results
None listed