Obstructive Sleep Apnoea (OSA) MedDRA version: 18.0 Level: LLT Classification code 10029983 Term: Obstructive sleep apnoea syndrome System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Morphine sulphate (generic), no trade name
Product Name: Morphine Sulphate
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of a
Sponsors
Papworth Hospital NHS Foundation Trust - Research and Development Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 18 years 2.Patients with a diagnosis of moderate OSA diagnosed by nocturnal oximetry, rPSG or PSG (defined as AHI or ODI of 15-29 events/hour) established on Continuous Positive Airway Pressure (CPAP) 3.Patients with confirmed moderate OSA by rPSG 6 nights after withdrawal of CPAP (baseline rPSG) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Inability to give informed consent or comply with the protocol 2.History of acute respiratory tract infection or chronic respiratory disease, symptomatic ischemic heart disease 3.Pregnancy or suspected pregnancy/breast feeding 4.Current or recent (within last week) use of hypnotic, opioid or sedative drugs 5.A known allergy to the IMP or NIMP(s) 6.Patients with an inadequate command of English and requiring an interpreter overnight 7.Change in weight of > 5% since the baseline rPSG 8.Vital signs recordings (oxygen saturations, blood pressure, pulse rate) that in clinician's opinion make it unsafe for the patient to participate in the trial 9.Clinician deems patient unsafe to participate in the trial (e.g. severely sleepy patients who cannot withdraw from CPAP) 10.CPAP intolerant/poor responder 11.History of Intravenous (iv) drug abuse 12.Patient unable to organise transport home following the study visit 13.Professional driver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the effect of morphine on the severity of Obstructive Sleep Apnoea (OSA) measured by Apnoea Hypopnoea Index (AHI - the number of pauses in breathing) in patients with known moderate OSA?;Secondary Objective: 1. To assess the effect of intravenous (iv) morphine on arterial oxygen desaturation index (the number of times per hour of sleep that the blood's oxygen level drops by 4 percent or more from baseline, ODI) of = 4% per hour measured during overnight sleep study (respiratory polygraphy, rPSG) 2. To assess the frequency of central apnoeas (due to a problem either in the drive to breathe which is generated within the brain or to weakness of the breathing muscles) obstructive apnoeas (due to the obstruction of the upper airway) and mixed apnoeic events (a combination of both central and obstructive apnoeic events) measured during the study rPSG 3. To measure the percentage of time spent with an arterial oxygen saturation (the amount of oxygen in the blood) of less than 90% during the study rPSG 4. To assess the safety endpoints of morphine administration. ;Primary end point(s): Change in Apnoea Hypopnoea Index (AHI) – change in mean number of apnoeas and hypopneas per hour of sleep from subject's baseline rPSG to the study rPSG. ;Timepoint(s) of evaluation of this end point: AHI is monitored during the overnight sleep study (rPSG). Patients will be monitored by rPSG during the treatment night when they receive either IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the following parameters from subject’s baseline rPSG study rPSG: 1.Arterial oxygen desaturation of = 4% per hour (Oxygen Desaturation Index, ODI) measured by pulse oximetry during the rPSG 2.Percentage of time with nocturnal saturations of = 90%- (SpO2= 90%) measured by pulse oximetry during the rPSG 3.To assess the number and severity of any adverse events associated with the IMP (morphine). ;Timepoint(s) of evaluation of this end point: All secondary variables are monitored during the overnight study (rPSG). Patients will be monitored by rPSG during the treatment night when they receive the IMP (morphine). | — |
Countries
United Kingdom
Contacts
Public ContactVictoria Stoneman
Papworth Hospital NHS Foundation Trust
Outcome results
None listed