Morphine in Moderate Obstructive Sleep Apnoea

• Status: Terminated
• Trial end date: 2018-06-06
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the effects of morphine (a drug commonly used for the treatment of moderate to severe pain, particularly following surgery) on the number of pauses in breathing in patients with moderate obstructive sleep apnoea (OSA). Morphine has been shown to reduce upper airway muscle tone and can also cause shallow breathing, which can affect breathing function in patients with sleep apnoea. However, to date these effects have not been proven in clinical trials. Although, caution is advised when prescribing morphine to patients with sleep apnoea, there is currently no strong evidence that morphine makes sleep apnoea worse. Only one randomised controlled trial (considered the gold standard in medical research) has shown no worsening of symptoms for patients with sleep apnoea. The effect of morphine on patients with sleep apnoea will be assessed in a safe, controlled, hospital environment. Information from the study will help inform doctors about the safety of giving morphine to patients with sleep apnoea in urgent situations, for example after surgery.

The results of this study will enable clinicians to make better decisions when prescribing this drug to patients with OSA in the future.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Papworth Hospital NHS Foundation Trust
• Treatments: Morphine

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