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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000028505

Acronym

OVEN-01

Enrollment

Registered

2015-01-19

Start date

2015-03-03

Completion date

2015-08-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results