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Trial registered on ANZCTR

Registration number

ACTRN12612000794808

Ethics application status

Approved

Date submitted

17/05/2012

Date registered

27/07/2012

Date last updated

19/07/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does changing the continuous positive airways pressure (CPAP) interface alter pressure requirements in patients with obstructive sleep apnoea

Scientific title

Does changing the continuous positive airways pressure (CPAP) interface alter pressure requirements in patients with obstructive sleep apnoea?
Nasal versus full face. Same pressure?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obstructive sleep apnea

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will be assigned to using an auto-titrating positive airways pressure (APAP) device overnight for 2 weeks using a nasal interface and two weeks using a full face interface. The nasal interface covers the nose only. The full face interface covers the nose and mouth. A full face interface may be used if a patient is unable to keep their mouth shut resulting in a pressure leak from the mouth. This therapy applies positive airways pressure to the upper airway and leaks result in a loss of effective pressure. As the full face mask sits lower on the face, it is postulated that adjusting the interface to seal the mask will apply pressure to the lower jaw. This may cause the jaw to be pulled back towards the airway causing the airway to narrow and thus a higher pressure may be required to maintain airway patency. The nasal interface sits above the top lip and any adjustment of this interface does not cause the jaw to move.

The first interface will be assigned in random order. This is a crossover study and there is no washout period between treatments.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Patients will be assigned to using an auto-titrating positive airways pressure device overnight for 2 weeks using a nasal interface and two weeks using a full face interface. The first interface will be assigned in random order. This is a crossover study and there is no washout period between treatments. The nasal interface will be deemed to be the control in this study.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure is required therapeutic pressure. This will be acquired from the downloaded data from the auto-titrating device which calculates the 95th centile pressure using a programmed algorithm.

Timepoint [1]

Required therapeutic pressure is measured after 2 weeks of each interface use.

Secondary outcome [1]

Patient's preference. This will be assessed by asking the patient which interface they prefer. They will also be given a Visual Analogue Scale at the end of each two week period to assess:
1) how comfortable was the mask
2) how well did it seal
3) how easy was it to use
They will also be asked to make any other comment about the mask.

Timepoint [1]

Patient's preference enquired after completion of study.

Eligibility

Key inclusion criteria

Patients who have been diagnosed with obstructive sleep apnoea and who are currently using CPAP therapy and are able to tolerate both a nasal interface and a full face interface.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pregnant women
Intellectually or mentally impaired patients
Patients highly dependant on medical care
Patients currently experiencing other problems with CPAP that affect their use of therapy

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)

Patients who are seen in the Sleep Disorders Centre who are on CPAP therapy and are able to tolerate both a nasal interface and a full face interface will be asked to participate. Patients will have the study explained to them and given a Participant Information Sheet. If agreeable, they will then be asked to sign the Consent Form which will be kept in the Sleep Disorders Centre. Patients will be assigned to undergo two weeks treatment using a nasal interface and two weeks using a full face interface in random order. Allocation is not concealed.

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

Simple randomisation by using a randomisation table created by computer software.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Random order crossover design.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/02/2010

Actual

16/02/2010

Date of last participant enrolment

Anticipated

Actual

7/03/2017

Date of last data collection

Anticipated

Actual

4/04/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Princess Alexandra Hospital

Address

199 Ipswich Road
Woolloongabba
Queensland
4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Alexandra Hospital Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee 
Centres for Health Research
Princess Alexandra Hospital 
199 Ipswich Road Woolloongabba
Queensland
4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/11/2009

Ethics approval number [1]

HREC/09/QPAH/244

Summary

Brief summary

Continuous positive airways pressure (CPAP) is the treatment of choice for patients who have obstructive sleep
apnoea (OSA). The patient wears an interface attached to a pump which delivers pressurized air to the upper airway,
thereby splinting the airway open. The interface is usually one of three types, nasal pillows which sit directly in the
nostrils, a nasal mask which covers the nose or a full-face mask which covers the nose and mouth. The nasal pillows
and nasal mask require the patient to keep their mouth closed during treatment as opening the mouth releases
pressure and this mouth leak results in less air pressure in the upper airway where it is required to splint the airway.
The full-face mask ensures the nose and mouth are both in the pressurised area and thus prevents mouth leak from
being a problem. Although the difference in dead space between the interfaces has been examined, the effect of the mechanical pressure from the headgear on the position of the lower jaw which is required to seal the full-face mask
has not been clearly assessed. The force applied to the headgear to seal the full-face mask may result in the lower
jaw being pushed back and thus the diameter of the upper airway being reduced. If this occurs, a higher CPAP
pressure would be required to splint the airway. An alternative treatment for OSA is the mandibular advancement splint which relies on a dental device to pull the jaw forward to enlarge the airway opening. It is not unreasonable to presume that pressure in the reverse direction would have the opposite effect. This study aims to assess the pressure requirements of nasal versus full-face mask in patients with OSA by using auto-titrating continuous positive airways pressure (APAP).The APAP devices sense flow limitation and snore and respond to these by increasing or decreasing the positive airways pressure as required. The downloaded data can be examined to assess the pressure requirements of the patient. Patients will be assessed in a random order, crossover study comprising a two week period each of a suitably fitted nasal interface and a suitably fitted full-face interface. As the data will be collected over a two week period, night to night variation should be minimised. The APAP will assess the pressure requirements for each period to examine if there is any difference in pressure requirements between the two interfaces. The Mallampati score and pharyngeal dimensions will also be evaluated to examine if this is a possible pre-disposing factor.

Trial website

Trial related presentations / publications

22nd Annual Scientific Meeting of the Australasian Sleep Association and Australasian Sleep Technologists Association, Christchurch, New Zealand, 21-23 October 2010: Poster presentation with oral component.

Public notes

Contacts

Principal investigator

Name

Mrs Teresa Shirlaw

Address

Sleep Disorders Centre Princess Alexandra Hospital Ipswich road Woolloongabba Queensland 4102

Country

Australia

Phone

+61 7 3176 5751

Fax

teresa.shirlaw@health.qld.gov.au

Contact person for public queries

Name

Teresa Shirlaw

Address

Sleep Disorders Centre
Princess Alexandra Hospital
Ipswich road
Woolloongabba Queensland 4102

Country

Australia

Phone

+61 7 3176 5751

Fax

+61 7 3176 7096

teresa.shirlaw@health.qld.gov.au

Contact person for scientific queries

Name

Teresa Shirlaw

Address

Sleep Disorders Centre
Princess Alexandra Hospital
Ipswich road
Woolloongabba Queensland 4102

Country

Australia

Phone

+61 7 3176 5751

Fax

+61 7 3176 5751

teresa.shirlaw@health.qld.gov.au

No information has been provided regarding IPD availability

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

No additional documents have been identified.

Trial Review

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