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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000028505
• Date of registration: 19/01/2015
• Prospective Registration: Yes
• Primary sponsor: Oventus Pty Ltd
• 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.
• Date of first enrolment: 03/03/2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000028505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Australia

Contacts

• Name: Dr Chris Hart

• Name: Mr Neil Anderson

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory - Sleep apnoea

Mild to moderate obstructive sleep apnoea;Snoring;
Mild to moderate obstructive sleep apnoea
Snoring

Intervention(s)

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.

Primary Outcome(s)

Change in apnoea hypopnoea index (AHI.)[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(s)

Change in respiratory disturbance index (RDI)[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).]

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).
[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 ID(s)

NIL

Source(s) of Monetary Support

Oventus Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Limited