Obstructive Sleep Apnoea Clinical Trial
Official title:
The Effect of Acute Intravenous Morphine Administration on Sleep Disordered Breathing (SDB) in Patients With Moderate Obstructive Sleep Apnoea (OSA): A Paired Design Trial
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.
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 estimated that at present 80% of sufferers
are undiagnosed. It must therefore be assumed that some of these patients are referred for
surgery.
Morphine, opiates and opioids remain the treatment of choice for moderate and severe pain
relief. Inevitably, a large number of patients will be presenting for surgery and receiving
postoperative opioid analgesia. Opioids may reduce respiratory rate and tidal volume,
decrease chemoresponsiveness to hypercapnia/hypoxia as well as decrease upper airway muscle
tone. These effects might further impair respiratory function in patients with SDB. There is
limited data showing increased extubation complications, increased incidence of paradoxical
breathing patterns and pronounced oxygen desaturations in patients with SDB receiving
opioid-based analgesia, but only one randomised controlled trial examining the effect of an
opioid in subjects with SDB.
Therefore, the current evidence base regarding the management of patients with OSA and their
peri-operative risk is sparse. As such the current recommendation from the American Society
of Anaesthesiologists to limit the use of opioids in such patients, is based on expert
opinion only. Indeed the effect of opioid analgesia on patients with SDB remains poorly
understood, making informed decisions when prescribing such substances to patients with SDB a
challenge.
This prospective, paired design trial will investigate the effect of intravenous morphine
sulphate on respiration during sleep in patients with moderate OSA.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01620554 -
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
|
Phase 2 | |
Not yet recruiting |
NCT01985347 -
The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study
|
N/A | |
Completed |
NCT01312558 -
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
|
N/A | |
Completed |
NCT02967536 -
Investigating the Neuropathology of Obstructive Sleep Apnoea
|
||
Completed |
NCT02855515 -
Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea
|
N/A | |
Recruiting |
NCT04262986 -
A Brief Lifestyle Modification Programme in Overweight Subjects With Obstructive Sleep Apnoea - Needs Assessment
|
||
Completed |
NCT03145129 -
PAIR Study-PAP And IOP Relationship: Study 2
|
||
Completed |
NCT02713152 -
Prevalence of Obstructive Sleep Apnoea in Glaucoma
|
N/A | |
Completed |
NCT06376305 -
EndoBarrier in Obstructive Sleep Apnoea Study
|
N/A | |
Completed |
NCT01661712 -
Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea
|
N/A | |
Terminated |
NCT01530451 -
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
|
Phase 3 | |
Completed |
NCT02518633 -
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction
|
N/A | |
Completed |
NCT01557166 -
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALEā¢ - Sleep Apnoea
|
Phase 3 | |
Recruiting |
NCT01829854 -
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery
|
N/A | |
Completed |
NCT01619748 -
Peripheral Vascular Function in Obstructive Sleep Apnoea
|
N/A | |
Completed |
NCT02417584 -
Efficacy of PAP Therapy on Blood Pressure
|
N/A | |
Completed |
NCT04071860 -
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
|
||
Not yet recruiting |
NCT04607343 -
Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea
|
N/A | |
Completed |
NCT01546792 -
Lifestyle Intervention in Obstructive Sleep Apnoea
|
Phase 2/Phase 3 | |
Completed |
NCT00300599 -
Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea
|
N/A |