Cooperative Research Centre (CRC) for Alertness, Safety and Productivity: Respiratory Phenotyping for Obstructive Sleep Apnoea

Efficacy and acceptability of oxygen versus CPAP treatment for people who have obstructive sleep apnoea known to respond to oxygen therapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000069550

Acronym

CRC RPOSA

Enrollment

Registered

2015-01-27

Start date

2015-04-09

Completion date

Unknown

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

Study hypothesis: Current clinical management of OSA is to use continuous positive airways pressure (CPAP) as a first-line treatment, and CPAP is approved in Australia for this purpose. Some people find CPAP difficult to tolerate and sleep with, so other treatments may be useful. Oxygen therapy is one form of treatment that could potentially treat OSA patients with unstable breathing control as the key factor underlying OSA. Primary purpose: The aim of this study is to test if oxygen therapy is an effective and acceptable alternative treatment to CPAP for patients with unstable breathing control underlying their OSA.

Interventions

Oxygen therapy delivered via nasal cannulae Dose: 4L/min via an oxygen concentrator (~93% oxygen) Frequency and duration of administration: One month, each night during sleep for as close as possible to the entire sleep period. Period between treatments: Approximately one week Setting for use of oxygen therapy: Participant's home

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Diagnosed with obstructive sleep apnoea (OSA) - Recommended usual care with CPAP treatment by their treating physician - Demonstrated positive treatment response to one night of oxygen therapy (O2 AHI <10 /hr with a =50% reduction compared to the air control night; using modified AHI scoring criteria without SaO2 signal blinding and no desaturation criteria).

Exclusion criteria

- Smokers (due to risk of fire with home oxygen use) - Women who are pregnant or who are trying to conceive - Children and/or young people (i.e. < 18 years) - Central sleep apnea (central apnea index >5 /hr) - Any relevant significant co-morbidity including respiratory (COPD) or psychiatric disorders likely to place the patient at higher than normal risk or likely to confound experimental treatment outcomes. - Physician recommended exclusion - Patient unable (e.g. language difficulties) or unwilling to consent

Outcome results