Oxygen as Second-Line Therapy for Obstructive Sleep Apnoea.

A parallel group, placebo controlled, randomised trial of oxygen supplementation for obstructive sleep apnea in those that have refused or failed continuous positive airway pressure treatment.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000006842

Enrollment

114

Registered

2012-01-03

Start date

2012-01-30

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

We aim to develop alternative treatments in patients refusing CPAP therapy. We hypothesize that 2 months of low-flow oxygen compared with room air, each delivered via nasal cannulae will improve sleep-disordered breathing, hypoxia during sleep, symptoms and maladaptive cardiovascular response in patients with OSA refusing CPAP treatment. Secondly, we hypothesize that patients with higher loop gain will derive a greater benefit (reduction in apnoea-hypopnoea index) from oxygen therapy.

Interventions

Oxygen. To be administered every night during sleep at a flow rate of 3L/min via nasal cannulae for 2 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Obstructive sleep apnoea (AHI greater than 15 events per hour) Refused, or unable to tolerate continuous positive airway pressure treatment

Exclusion criteria

Using other therapy for obstructive sleep apnoea - i.e. mandibular advancement splint Waking hypoxaemia (SaO2 less than 95%) BMI greater than 38 Severe COPD or other lung disease Uncontrolled cardiac disease Participant or household member currently smoking Severe nasal occlusion

Outcome results