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Trial registered on ANZCTR


Registration number
ACTRN12615000028505
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
19/01/2015
Date last updated
9/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, single arm, single centre pilot trial to establish the safety and efficacy of the Oventus device to treat mild to moderate obstructive sleep apnoea and snoring.
Scientific title
A prospective, single arm, single centre pilot trial to establish the safety and efficacy of the Oventus device to treat mild to moderate obstructive sleep apnoea and snoring.
Secondary ID [1] 285769 0
NIL
Universal Trial Number (UTN)
Trial acronym
OVEN-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate obstructive sleep apnoea 293651 0
Snoring 293652 0
Condition category
Condition code
Respiratory 293948 293948 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oventus oral mandibular advancement device is worn during sleep. It is anticipated that the device will be worn between 6-8 hours per night every night for 2-6 weeks (determined by patient preference). Device fitting will take 1-2 hours during the initial fit and may be adjusted up to 4 times during the study which will take a further 30-60 minutes each adjustment.
Intervention code [1] 290728 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293723 0
Change in apnoea hypopnoea index (AHI.)
Timepoint [1] 293723 0
There is no fixed primary time point for this study as the device is titrated until properly fitted. Titration is anticipated to take between 2 and 6 weeks. The design of the study allows for three follow-up polysomnography studies to be conducted after the initial fitting and up to four separate titrations. The primary time point is therefore between 2 and 6 weeks.

Secondary outcome [1] 311664 0
Change in snoring grade. The snoring grade is recognised by healthcare professionals including the NHS (public health care system of the United Kingdom). The snoring grades are
(1) Grade One - Infrequent snoring that is not particularly loud and does not disrupt breathing.
(2) Grade Two - Regular snoring with associated breathing difficulties that can affect the quality of sleep.
(3) Grade Three - Snoring every night that may well be related to obstructive sleep apnoea (OSA).
Timepoint [1] 311664 0
The secondary time point is expected to occur between 2-6 weeks depending on how long it takes to properly fit the Oventus device (titration of the device).
Secondary outcome [2] 311665 0
Change in respiratory disturbance index (RDI)
Timepoint [2] 311665 0
The secondary time point is expected to occur between 2-6 weeks depending on how long it takes to properly fit the Oventus device (titration of the device).

Eligibility
Key inclusion criteria
Age equal to or greater than 18, mild to moderate AHI (between 5-30), eligible to receive a mandibular advancement device, grade 2-3 snoring, intact top row of teeth, able top provide written consent and adhere to protocol requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or lactating females, participating in another clinical trial, periodontal disease, exaggerated gag reflex, medication usage that could influence respiration or sleep, obstructive sleep apnoea with uncontrolled or untreated cardiovascular disease, central sleep apnoea events greater than 5 per hour.

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)
Participants must be eligible for a mandibular advancement device. Once eligibility is confirmed, the participant will have a baseline polysomnography study completed (sleep study) to verify obstructive sleep apnoea and collect baseline information. The participant will then be fitted with an Oventus oral appliance and return for up to 3 follow-up polysomnography studies.
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
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is an exploratory pilot study aimed at determining the degree of benefit of the device on the AHI score at 1 month. A benefit is measured as a greater than or equal to 50% improvement in the AHI. It is anticipated that, under usual care (weight loss etc.), the longer term reduction of greater than or equal to 50% (a 'success') for these patients in the AHI is at most 5%. An improvement of AHI to greater than or equal to 50% in 20% of the patients would be considered clinically worthwhile to warrant further investigation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9009 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 290334 0
Commercial sector/Industry
Name [1] 290334 0
Oventus Pty Ltd
Address [1] 290334 0
Level 32, 1 Market Street, Sydney, NSW, 2000
Country [1] 290334 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Oventus Pty Ltd
Address
Level 32, 1 Market Street, Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 289051 0
None
Name [1] 289051 0
Address [1] 289051 0
Country [1] 289051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292040 0
Bellberry Limited
Ethics committee address [1] 292040 0
129 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 292040 0
Australia
Date submitted for ethics approval [1] 292040 0
Approval date [1] 292040 0
12/09/2014
Ethics approval number [1] 292040 0
2014-07-402

Summary
Brief summary
The purpose of the study is to reduce the symptoms of mild to moderate obstructive sleep apnoea (OSA) and snoring using the Oventus oral appliance. Sleep apnoea is assigned an apnoea hypopnoea index (AHI) number which indicates the severity of OSA. The aim of the study is to reduce AHI by at least 50% in at least 20% of the participants in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53186 0
Dr Damian Lavery
Address 53186 0
Turbot Street Medical Centre
Spring Hill Market Place
Shop 9, 375 Turbot Street
Spring Hill, QLD, 4000
Country 53186 0
Australia
Phone 53186 0
+61 432 597 142
Fax 53186 0
Email 53186 0
damianlavery@optusnet.com.au
Contact person for public queries
Name 53187 0
Mr Neil Anderson
Address 53187 0
Oventus Pty Ltd,
Level 32, 1 Market Street
Sydney, NSW, 2000
Country 53187 0
Australia
Phone 53187 0
+61 403 003 475
Fax 53187 0
Email 53187 0
neil@oventus.com
Contact person for scientific queries
Name 53188 0
Dr Chris Hart
Address 53188 0
Turbot Street Medical Centre
Spring Hill Market Place
Shop 9, 375 Turbot Street
Spring Hill, QLD, 4000
Country 53188 0
Australia
Phone 53188 0
+61 409 647 496
Fax 53188 0
Email 53188 0
chris@oventus.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary