RecruitingACTRN12616001514493

The effect of upper airway surgery on obstructive sleep apnoea

The effect of upper airway surgery on pathophysiological traits known to contribute to obstructive sleep apnoea


Sponsor

Monash Health

Enrollment

80 participants

Start Date

Jan 19, 2017

Study Type

Interventional

Conditions

Summary

Obstructive sleep apnoea (OSA) affects 1.5 million Australians and results in significant morbidity and mortality. However, half of patients cannot tolerate the leading treatment, continuous positive airways pressure (CPAP). For those intolerant of CPAP, a common treatment alternative involves upper airway surgery (UAS). Unfortunately, a significant number of patients referred for this treatment do not respond and suffer from residual OSA with its inherent cardiovascular and neurocognitive consequences. Furthermore, current clinical predictive tools are poor at identifying responders to UAS and there are no proven additional therapies to offer those patients failing UAS treatment. The key to providing better predictors of OSA resolution with UAS is to understand how these interventions affect the physiology responsible for OSA. It is clear that UAS improves upper airway anatomy/collapsibility. However, poor upper airway anatomy is not the only factor contributing to OSA. Recent evidence suggests that several additional, non­anatomical, physiological traits contribute to the pathogenesis of OSA including: 1) an oversensitive ventilatory control system (i.e. high loop gain), 2) a low respiratory arousal threshold, and 3) poor pharyngeal dilator muscle effectiveness characterised by an inability of the pharyngeal muscles to hold open or stiffen the airway during sleep. However, it is not known how UAS alter these non­anatomical traits and whether abnormalities in these traits are the reason for the variability in the success of UAS treatments. Furthermore, it is also not known if targeting non­ anatomical traits with additional treatments (i.e. combination therapy) will improve outcomes for those patients who have had only a partial response to UAS. Our goal is to be able to accurately identify which OSA patients are good candidates for UAS therapy by identifying robust predictors of OSA resolution with these interventions. Furthermore, we aim to offer additional treatments to ‘salvage’ those patients who have failed to respond completely to UAS.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria2

  • Confirmed diagnosis of obstructive sleep apnoea with an apnoea/hypopnoea index of greater than or equal to 15 events/hr. Diagnosis must be on level 1 or 2 sleep study and have occurred within at least 6 months enrolment into the trial.
  • Patients deemed appropriate and likely to respond to anatomically directed upper airway surgery as determined by staff specialists of the The Ear, Nose and Throat/Head and Neck Surgery Unit, Monash Health.

Exclusion Criteria3

  • Significant co-morbid medical issues that would preclude surgery.
  • Administration of medications/drugs that interfere with ventilatory control.
  • Previous upper airway surgery for obstructive sleep apnoea. Patients cannot have any metallic implants/prostheses that would preclude magnetic resonance imaging (MRI) scanning.

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Interventions

The intervention for this study is anatomically directed upper airway surgery with the aim of resolving obstructive sleep apnoea. The specific set of operations performed will be tailored to each pat

The intervention for this study is anatomically directed upper airway surgery with the aim of resolving obstructive sleep apnoea. The specific set of operations performed will be tailored to each patient based on a comprehensive assessment of upper airway anatomy performed by staff specialist Ear Nose and Throat surgeons at Monash Health - a tertiary university teaching hospital. The operations may include one or more of: turbinate surgery, septoplasty, modified uvulopalatopharyngeoplasty, adenoid surgery, palatine tonsil surgery, lingual tonsil surgery, tongue channelling. Typically the combination of surgical procedures will be performed in one separation but in certain circumstances the combination of operations may be performed over 2 or more separations. The duration of the operating procedure is contingent upon the combination of procedures performed but would typically occur over 1-2hrs. Surgery will be conducted at Monash Health by staff of The Ear, Nose and Throat/Head and Neck Surgery Unit, Monash Health. Follow-up to determine effect on obstructive sleep apnoea will occur 3 months post surgery.


Locations(2)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Monash Medical Centre - Moorabbin campus - East Bentleigh

VIC, Australia

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ACTRN12616001514493