Morphine in Moderate Obstructive Sleep Apnoea

Launched by PAPWORTH HOSPITAL NHS FOUNDATION TRUST · Apr 20, 2017

Keywords

ClinConnect Summary

Sleep Disordered Breathing (SDB) is a term used to cover a range of breathing events encountered during sleep and includes Obstructive Sleep Apnoea (OSA). OSA is the most common form of SDB and is caused by partial or complete upper airway occlusion during sleep leading to repetitive arousals to restore the airway patency. These frequent, obstructive events can be associated with symptoms of unrefreshing sleep and adverse health outcomes. The incidence of OSA is increasing due to rising levels of obesity, which has been identified as the strongest risk factor for developing OSA. It is estim...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Patients with diagnosis of moderate or severeOSA at screening, diagnosed by nocturnal oximetry, rPSG or PSG (defined as AHI or ODI of 15-50 events/hour) established on Continuous Positive Airway Pressure (CPAP)
• • 3. Patients established on CPAP with confirmed moderate OSA (AHI 15-29 events/hr) 6 nights after withdrawal of CPAP (confirmed at baseline rPSG)
• • 4. Patients diagnosed with moderate OSA by rPSG or PSG, naïve to CPAP treatment
• Exclusion Criteria:
• • Inability to give informed consent or comply with the protocol
• • Current, clinically significant acute respiratory tract infection (at screening and at study visit)
• • Chronic respiratory disease (other than OSA), symptomatic ischemic heart disease
• • Pregnancy or suspected pregnancy/breast feeding
• • Current or recent (within last week of entering the trial and for the duration fo the trial) use of gabapentin, pregabalin, melatonin, mirtazapine, benzodiazepines, barbiturates, sodium oxybate, ramelteon, Z-drugs and opiates/opioids
• • Monoamine oxidase inhibitors (MAOIs), linezolid taken within two weeks of participation in the trial
• • A known allergy to the investigational medicinal product (IMP) or non investigational medicinal product(s) (NIMP)(s)
• • Patients with an inadequate command of English and such that an interpreter would be required overnight
• • Change in weight of greater than 5% since the baseline rPSG
• • Vital signs recordings (oxygen saturations, blood pressure, pulse rate) that in the clinician's opinion deem the patient unsafe to participate in the trial
• • Clinician deems the patient unsafe to participate in the trial (e.g. severely sleepy patients who cannot withdraw from CPAP)
• • CPAP intolerant/poor responder
• • History of drug abuse (oral and intravenous) including: alcohol, substituted amphetamines, barbiturates, benzodiazepines, cocaine, methaqualone, cannabis and opioids
• • A drop of oxygen saturations below 85% continuously for longer than five minutes during the baseline rPSG
• • Professional driver