None listed
Conditions
Brief summary
Brief summary: Current clinical management of OSA is to use continuous positive airway pressure (CPAP) as a first-line treatment. However, patient tolerance and compliance with CPAP is an ongoing problem in sleep medicine. This study recognizes that alternative treatments better targeted to underlying causal deficits may lead to improved treatment outcomes for patients. Oxygen therapy combined with a sedative (Zopiclone) is one form of combination treatment that could potentially treat a sub-group of OSA patients who have unstable breathing and heightened awakening responses underpinning their OSA. The aim of this study is to investigate if oxygen combined with a commonly used sedative, Zopiclone, could be used to effectively treatment OSA in some patients. Participants will be recruited from the study “CRC Respiratory Phenotyping for Obstructive Sleep Apnea”. The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Interventions
Descriptions of intervention(s) / exposure: Interventions: Zopiclone and oxygen
This is a pilot study of combination treatment with Zopiclone and oxygen so both will be administered on the same night.
Zopiclone
a) Dose administered: 7.5 mg
b) Duration of administration: single administration, just prior to bedtime, during the overnight laboratory study visit for polysomnography.
c) Mode of administration: oral tablet
d) Details of study visits required: single overnight laboratory study vis
Descriptions of intervention(s) / exposure: Interventions: Zopiclone and oxygen This is a pilot study of combination treatment with Zopiclone and oxygen so both will be administered on the same night. Zopiclone a) Dose administered: 7.5 mg b) Duration of administration: single administration, just prior to bedtime, during the overnight laboratory study visit for polysomnography. c) Mode of administration: oral tablet d) Details of study visits required: single overnight laboratory study visit for polysomnography. e) Strategy to monitor adherence: oral ingestion of tablet to be witnessed by research staff. Oxygen a) Dose administered: 4L/min b) Duration of administration: throughout a single overnight laboratory study visit for polysomnography, from just prior to bedtime to final wake up time. c) Mode of administration: delivered by nasal cannula d) Details of study visits required: single overnight laboratory study visit for polysomnography. e) Strategy to monitor adherence: Research staff monitoring of cannula placement and flow rate Outcomes will be compared to a baseline (diagnostic) sleep study, which is collected as part of standard clinical practice for the diagnosis of Obstructive Sleep Apnoea (see inclusion criteria). Comparisons will also be made to separate air and O2 study nights collected as part of the main study (ACTRN12615000918527). Baseline (diagnostic) sleep studies will be conducted from April 2015 – December 2017. The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Sponsors
A/Prof Peter Catcheside
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosed with obstructive sleep apnoea (OSA) - Demonstrated partial treatment response to one night of oxygen therapy (defined as AHI being reduced by 50% or more on oxygen versus air, but AHI on oxygen still greater than or equal to 10/hour), as part of the study CRC Respiratory Phenotyping for Obstructive Sleep Apnea. The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).
Exclusion criteria
- A history of significant COPD (gold criteria 3-4), chronic ventilatory failure from any other cause or psychiatric disorders likely to place the patient at a higher than normal risk or likely to confound experimental treatment outcomes. - Age >65 years - Pregnancy or nursing mother - Any major contra-indication for Zopiclone (known hypersensitivity to Zopiclone or any of the excipients, prior or concomitant use of alcohol, myasthenia gravis, severe impairments of hepatic function and acute cerebrovascular accident). - Physician recommended exclusion - Patient unable (i.e. language difficulties) or unwilling to consent - Central sleep apnoea (central apnea index >5 /hr)
Outcome results
None listed