ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001361392

Ethics application status

Approved

Date submitted

30/08/2017

Date registered

27/09/2017

Date last updated

8/08/2019

Date data sharing statement initially provided

8/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Oxygen therapy for treating patients with residual sleep apnoea following upper airway surgery

Scientific title

Oxygen therapy for treating patients with residual obstructive sleep apnoea following upper airway surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obstructive Sleep Apnoea

Condition category

Condition code

Respiratory

Sleep apnoea

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Oxygen therapy will be administered to patients as they sleep in the sleep laboratory at Monash Medical Centre.
100% Oxygen will be administered at a flow rate of 4L/min via nasal cannula.
The treatment will be administered by trial investigators who are sleep scientist/technicians employed by Monash Health and who are experienced in delivering oxygen to sleeping patients which they do as part of their routine work.
The Oxygen treatment will be delivered over a single night of sleep (typically 6-7hrs), i.e. one session.
The control/placebo treatment will be Room Air delivered at a flow rate of 4L/min via nasal cannula.
The control/placebo will be delivered continuously while patients sleep (typically 6-7hrs).
Sleep studies will be conducted within one week of one another.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The control treatment is Room Air delivered at 4L/min via nasal cannula.

Control group

Placebo

Outcomes

Primary outcome [1]

Apnea hypopnea index

Timepoint [1]

On the study night where the treatment intervention is administered and when the control intervention is administered (i.e. study night one and study night two).

Secondary outcome [1]

Blood pressure

Timepoint [1]

taken before and after study night one and two in the same arm.

Secondary outcome [2]

Pulse oximetry

Timepoint [2]

Recorded continuously in study night one and study night two.

Secondary outcome [3]

Arousal index

Timepoint [3]

recorded continuously during study night one and study night two.

Eligibility

Key inclusion criteria

Patients will be selected from a cohort of patients suffering from obstructive sleep apnoea who have had upper airway surgery to treat their sleep apnoea but who have failed to respond to surgical treatment and who have ongoing sleep apnoea.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Nil.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Allocation is not concealed.

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

Simple randomisation using a randomisation table generated by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Each patient will undergo a sleep study on both the treatment and on the control, as such each patient will act as their own control.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary and secondary end points will be compared between the study night on treatment and the study night on placebo. Group data will be compared via and independent samples t-test.
A responder analysis will be performed to determine patient factors that predict response to oxygen therapy treatment. The patients will be divided into responders/non-responders on the basis of the primary outcome measure on the treatment study night.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

18/08/2017

Date of last participant enrolment

Anticipated

30/08/2018

Actual

28/03/2018

Date of last data collection

Anticipated

30/10/2018

Actual

30/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Health

Address [1]

Monash Medical Centre
246 Clayton Rd
Clayton 3168, VIC

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

Monash Health, Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

Monash Health
246 Clayton Rd
Clayton, Vic, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/03/2017

Approval date [1]

05/05/2017

Ethics approval number [1]

HREC/17/MonH/128 or RES-17-0000-165A

Summary

Brief summary

Obstructive sleep apnoea (OSA) is a condition in which the upper airway of patients closes off during sleep.  This leads to low levels of oxygen and multiple awakenings during the night.  There are many factors contributing to the abnormal blockage of the upper airway including the shape, length and strength of the airway itself. Upper airway surgery can help influence these factors. However, there are still patients with residual sleep apnoea despite upper airway surgery.

The aim of this study is to test the impact of oxygen therapy in patients with residual sleep apnoea following upper airway surgery. Oxygen therapy will lower the sensitivity of participants ventilator control system and is expected to help further improve their OSA. The study is intended to discover if the combination of oxygen therapy and upper airway surgery can completely resolve OSA in patients where surgery is not able to resolve OSA on its own. 

The study will involve each identified participant to undergo two sleep studies over two nights. These visits will tell us if the administration of oxygen therapy after upper airway surgery can completely resolve OSA in patients who still snore. All participants will receive one night without oxygen, and one night with oxygen, to be used as a direct comparison. Measurements of breathing pattern, heart beat, blood pressure, muscle activity, eye movements, brain activity and the level of oxygen in the blood in the blood will be recorded and later interpreted by investigators specialized in OSA. 

We believe that the combination of oxygen and upper airway surgery could positively impact patients OSA and their quality of life. It can potentially provide additional treatment options for sufferers of residual OSA despite surgical management.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bradley Edwards

Address

Sleep and Circadian Medicine Laboratory
264 Ferntree Gully Road | Notting Hill, VIC 3168, Australia

Country

Australia

Phone

+61399050187

Fax

Bradley.Edwards@monash.edu

Contact person for public queries

Name

Michael Tan

Address

Monash Lung and Sleep
246 Clayton Rd
Clayton, Vic, 3168

Country

Australia

Phone

+61395942900

Fax

michael.tan@monashhealth.org.au

Contact person for scientific queries

Name

Bradley Edwards

Address

Sleep and Circadian Medicine Laboratory
264 Ferntree Gully Road | Notting Hill, VIC 3168, Australia

Country

Australia

Phone

+61399050187

Fax

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

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	A randomized controlled trial of oxygen therapy for patients who do not respond to upper airway surgery for obstructive sleep apnea.	2021	https://dx.doi.org/10.5664/jcsm.8920

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

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Documents added manually

Documents added automatically