None listed
Conditions
Brief summary
This study aims to investigate the effects of morphine on obstructive sleep apnoea (OSA). Specifically, we will measure the effects of a common clinical dose of morphine on sleep, respiratory control, and upper airway physiology.
Interventions
Study design: double-blind, placebo-controlled crossover study in male obstructive sleep apnea patients.
Treatment arm: Oral slow-release morphine tablets in capsules (40mg MS Contin) vs. placebo. Each intervention will be taken 4 hours before sleep. Patients will be monitored overnight.
1 week washout between sleep studies (a total of 2-4 nights will be required).
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Men aged between 18-65 years; BMI < 40 kg/m2; awake SpO2>90% - Screening PSG: OSA patients: AHI >= 5, SpO2 nadir >= 60%.
Exclusion criteria
- Do not meet the inclusion criteria listed above or unwilling to follow the study protocol. - Shift workers and/or patients with other significant sleep disorders such as PLMS. - Severe medical and/or psychiatric diseases other than sleep aponea. - History of drug abuse and/or urine drug test positive to narcotic or other illicit drugs and/or history of allergy to morphine. - Subjects with current physical complaints (eg. respiratory infections or rhinitis) will not be included until symptoms are clear for 4 weeks. - Certain concomitant CNS active drug use such as hypno-sedatives and antipsychotics. Antidepressants will not be a specific exclusion criteria. - Creatinine clearance (Cockroft-Gault) < 60 ml/min; LFTs > 2x ULN. - Patients with a known history of CO2 retention (PCO2>45mmHg during wakefulness).
Outcome results
None listed