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Nocturnal supplemental oxygen for obstructive sleep apnoea in patients with fibrotic interstitial lung disease

The effect of nocturnal supplemental oxygen for the management of obstructive sleep apnoea in patients with fibrotic interstitial lung disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001109897
Enrollment
10
Registered
2021-08-23
Start date
2022-05-02
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

None listed

Brief summary

Obstructive sleep apnoea (OSA) affects more than 50% of people with interstitial lung disease (ILD), with inadequate treatment due to poor compliance with current treatments such as CPAP and mouth splints. Supplemental oxygen is a potential treatment for OSA in people with ILD, which is readily available and easy to use, and ovenight oximetry may be helpful for establishing the diagnosis of OSA in people with ILD.

Interventions

Supplemental 100% oxygen at 5 litres/min via nasal cannulae during a single night of overnight polysomnography performed by a sleep scientist at a sleep laboratory. Participants who are using CPAP for the management of obstructive sleep apnoea will be temporarily ceasing CPAP for up to 14 days prior to the first night of overnight polysomnography. The two nights of overnight polysomnography will be performed within 4 weeks with at least 1 night in between each study, and a washout period is not

Supplemental 100% oxygen at 5 litres/min via nasal cannulae during a single night of overnight polysomnography performed by a sleep scientist at a sleep laboratory. Participants who are using CPAP for the management of obstructive sleep apnoea will be temporarily ceasing CPAP for up to 14 days prior to the first night of overnight polysomnography. The two nights of overnight polysomnography will be performed within 4 weeks with at least 1 night in between each study, and a washout period is not required. Participants will be given a pulse oximeter to wear over the fingertip for measurement of overnight oximetry at home over three individual nights without treatment.

Sponsors

Dr Yet Hong Khor
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age greater than or equal to 18 years 2. Able to give written informed consent 3. A multidisciplinary diagnosis of fibrotic interstitial lung disease of any aetiology 4. Suspected obstructive sleep apnoea or confirmed diagnosis of obstructive sleep apnoea using overnight polysomnography

Exclusion criteria

1. Use of or eligible for long-term oxygen therapy 2. Use of respiratory stimulants or depressants 3. Stable health condition (defined as hospitalisation for acute medical conditions) in the last 4 weeks before screening 4. Significant co-existing chronic obstructive pulmonary disease (defined as FEV1/FVC <60% on the most recent lung spirometry or extent of emphysema greater than extent of fibrosis on the most recent CT chest)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026