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Trial registered on ANZCTR

Registration number

ACTRN12616001514493

Ethics application status

Approved

Date submitted

31/10/2016

Date registered

3/11/2016

Date last updated

3/12/2020

Date data sharing statement initially provided

12/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of upper airway surgery on obstructive sleep apnoea

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obstructive sleep apnoea

Upper airway surgery

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Apnoea/hypopnoea index
Assessed by in laboratory polysomnography.

Timepoint [1]

3 to 6 months following surgery

Secondary outcome [1]

Steady state loop gain
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [1]

3 to 6 months following surgery

Secondary outcome [2]

Dynamic loop gain
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [2]

3 to 6 months following surgery

Secondary outcome [3]

Upper muscle responsiveness
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [3]

3 to 6 months following surgery

Secondary outcome [4]

Pharyngeal critical closing pressure
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [4]

3 to 6 months following surgery

Secondary outcome [5]

Arousal threshold
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [5]

3 to 6 months following surgery

Secondary outcome [6]

Body position specific apnoea/hypopnoea index
Assessed by in laboratory polysomnography.

Timepoint [6]

3 to 6 months following surgery

Secondary outcome [7]

Passive V0
Assessed during research polysomnography with continuous positive airways pressure.

Timepoint [7]

3 to 6 months following surgery

Secondary outcome [8]

Weight
Assessed with digital scales.

Timepoint [8]

3 to 6 months following surgery

Secondary outcome [9]

Body mass index

Timepoint [9]

3 to 6 months following surgery

Secondary outcome [10]

continuous positive airways pressure (CPAP) use
Assessed from CPAP device download and self report.

Timepoint [10]

3 to 6 months following surgery

Secondary outcome [11]

Friedman palate score

Timepoint [11]

3 to 6 months following surgery

Secondary outcome [12]

Friedman tonsil score

Timepoint [12]

3 to 6 months following surgery

Secondary outcome [13]

Mallampatti score assessed during physical examination.

Timepoint [13]

3 to 6 months following surgery

Secondary outcome [14]

Site of collapse at supine nasendoscopy

Timepoint [14]

3 to 6 months following surgery

Secondary outcome [15]

Epworth sleepiness score

Timepoint [15]

3 to 6 months following surgery

Secondary outcome [16]

Karolinska questionnaire to assess self reported sleepiness.

Timepoint [16]

3 to 6 months following surgery

Secondary outcome [17]

Functional Outcomes of Sleep Questionnaire

Timepoint [17]

3 to 6 months following surgery

Secondary outcome [18]

36 item short form health survey

Timepoint [18]

3 to 6 months following surgery

Secondary outcome [19]

Hospital Anxiety and Depression Scale

Timepoint [19]

3 to 6 months following surgery

Secondary outcome [20]

Snoring Apnoea Questionnaire

Timepoint [20]

3 to 6 months following surgery

Secondary outcome [21]

Magnetic Resonance Imaging characteristics of the upper airway

Timepoint [21]

3 to 6 months post surgery

Secondary outcome [22]

Nocturnal blood pressure measurement prior to and during sleep study

Timepoint [22]

3 to 6 months following surgery

Eligibility

Key inclusion criteria

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.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A sample size of 24 OSA patients will give 80% power with an alpha=0.05 to detect a reduction of 15+/-25 (SD) in AHI (values calculated from the mean reduction in AHI during application of mandibular advancement devices - another anatomically based treatment, in a previous study by our group). Therefore, in order to allow for participant attrition (~30%), 30 patients will be enrolled.

Significant improvement in AHI and the OSA traits pre- and post-surgery will be assessed using paired Students t-test. If our data are non-parametric, the appropriate nonparametric tests (i.e. Mann-Whitney) will be used.

With regard to the secondary endpoint of 24hr blood pressure measurement, we have calculated that a sample size of 60 OSA patients will give 80% power with an alpha=0.05 to detect a reduction of -1.5±4.0mmHg in mean 24-hr blood pressure.

All patients who are enrolled for the purpose of measuring pre and post surgery traits will be invited to participate in the blood pressure project. With any further recruits only being required to complete the blood pressure project.

Data from the research polysomnogram (PSG) will provide baseline pathophysiological information for each patient. Multiple linear regression will be conducted to determine which baseline clinical and physiological variables are independently related to the greatest therapeutic reduction OSA severity (measured by apnoea-hypopnoea index, AHI). Furthermore we will conduct a 'responder' versus 'non-responder' analysis. Briefly, patients will be classified as a responder to surgery if they demonstrate a 50% reduction in their AHI & an AHI on therapy of less than 10 events per hour. Independent samples t-tests (or non-parametric equivalent) will then assess which baseline clinical and physiological variables separate 'responders' from 'non-responders'.
Changes in magnetic resonance imaging (MRI) characteristics pre- and post-surgery will be assessed using paired Student's t-test.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/12/2016

Actual

19/01/2017

Date of last participant enrolment

Anticipated

31/12/2020

Actual

Date of last data collection

Anticipated

30/06/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3165 - East Bentleigh

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

School of Clinical Sciences
Monash Medical Centre
246 Clayton Rd
Clayton 3168, Victoria.

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

Monash Health - Monash Medical Centre
246 Clayton Rd
Clayton 3168, Victoria.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Monash University

Address [1]

Sleep and Circadian Laboratory
Ground Floor BASE Facility
246 Ferntreegully Rd
Notting Hill
Victoria 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Monash Health
246 Clayton Rd
Clayton 3168
Victoria, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/04/2016

Approval date [1]

03/08/2016

Ethics approval number [1]

16207A

Summary

Brief 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bradley Edwards

Address

Sleep and Circadian Medicine Laboratory, Department of Physiology and
School of Psychological Sciences
Faculty of Medicine, Nursing and Health Sciences, Monash University
264 Ferntree Gully Road
Notting Hill,
Victoria 3168

Country

Australia

Phone

+613 9905 0187

Fax

+613 9905 3948

bradley.edwards@monash.edu

Contact person for public queries

Name

Luke Thomson

Address

Sleep and Circadian Medicine Laboratory, Department of Physiology and School of Psychological Sciences Faculty of Medicine, Nursing and Health Sciences, Monash University 264 Ferntree Gully Road Notting Hill, Victoria 3168

Country

Australia

Phone

+613 9905 4716

Fax

luke.thomson@monash.edu

Contact person for scientific queries

Name

Bradley Edwards

Address

Sleep and Circadian Medicine Laboratory , Department of Physiology and
School of Psychological Sciences
Faculty of Medicine, Nursing and Health Sciences,Monash University
264 Ferntree Gully Road
Notting Hill,
Victoria 3168

Country

Australia

Phone

+613 9905 0187

Fax

+613 9905 3948

bradley.edwards@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Do not have specific ethics approval to share IPD

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Examining the impact of multilevel upper airway surgery on the obstructive sleep apnoea endotypes and their utility in predicting surgical outcomes.	2022	https://dx.doi.org/10.1111/resp.14280

N.B. These documents automatically identified may not have been verified by the study sponsor.

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