None listed
Conditions
Brief summary
Like other oral appliances to treat snoring and sleep apnoea, the O2Vent brings the jaw forward to reduce airway collapse. However, it also has a built in airway to allow breathing through the device. This may make it suitable for use by patients who find it difficult to breathe exclusively through the nose. A recent pilot study showed that original design, the Oventus Clearway, was safe, effective and well tolerated with a 62% reduction in the number of times patients stopped or reduced their breathing during sleep. No difference in response rate was observed in patients with or without subjective symptoms of nasal congestion. The new generation Oventus device, the O2Vent, has the built in airway of the original design, however it is 2 parts, an upper and lower part. This makes it much easier to adjust and find the optimal jaw position.. The aims of the present study are to: 1. To demonstrate safety and efficacy of O2Vent oral appliance 2. To demonstrate that the incorporation of an enclosed airway into the O2Vent improves comfort and compliance 3. To confirm the equivalent response rate in subjects with nasal congestion using rhinomanometry as an objective measure of nasal congestion The above aims will be addressed using a randomized crossover study design with patients in one arm using the O2Vent with the built in airway open and in the other arm using the device with the built in airway closed.
Interventions
The Oventus O2Vent is an oral appliance similar in appearance to a mouth guard. It is a modification to the Oventus Clearway, designed to treat snoring and sleep apnoea. It is made up of two parts. The main structure which forms the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from polished medical grade titanium with a polymer insert. The lower portion is made from dual laminate and is positioned in an advanced position to bring the jaw f
The Oventus O2Vent is an oral appliance similar in appearance to a mouth guard. It is a modification to the Oventus Clearway, designed to treat snoring and sleep apnoea. It is made up of two parts. The main structure which forms the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from polished medical grade titanium with a polymer insert. The lower portion is made from dual laminate and is positioned in an advanced position to bring the jaw forward. Further adjustment of the jaw position is much easier with a screw mechanism. The device will be delivered by a dentist in a dedicated dental clinic. Eligibility for a dental appliance will have been confirmed on a visit prior to enrollment into the trial. The appliance is custom made and has a built in airway to allow airflow through the device. The device will be fitted by the dentist with either the built in airway open (Treatment 1) or closed (Treatment 2). During the dental fitting, the dentist will check the fit of the appliance and provide instructions on use and cleaning. The device will be worn every night during sleep and removed on waking for the duration of the study. During an acclimatization phase of 2-8 weeks, ongoing symptoms, side effects, comfort and usage will be assessed via questionnaires every 2 weeks and device adjusted to achieve optimal lower jaw advancement. When treatment has been optimized, efficacy may be confirmed using a level 3 home sleep study to inform clinical opinion that treatment is optimized. Comfort and compliance will then be assessed using a questionnaire and sleep diary over a 2 week period with efficacy established on a level 1 in laboratory sleep study at the end of the 2 weeks.. Participants will then cross over into the other Treatment group and comfort, compliance and efficacy assessed over a 2 week period as described.. In the interest of not withdrawing treatment, there is no washout period between the 2 treatment arms.
Sponsors
Oventus Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years old. 2. Obstructive sleep apnoea as diagnosed by a sleep physician within the last 12 months (diagnoses from polysomnography) and: a) Recommended for oral appliance therapy as at least part of the treatment or b) Recommended CPAP but are CPAP Intolerant as documented by affidavit. 3. Eligible to receive a mandibular advancement device 4. Must have at least 8 upper and 8 lower teeth 5. Is able to provide written informed consent to all study procedures and agrees to adhere to all protocol requirements.
Exclusion criteria
1. Pregnant or lactating females 2. Participating in another clinical trial 3. Periodontal disease 4. Exaggerated gag reflex 5. Medication usage that could influence respiration or sleep (e.g. regular use of sedatives, heavy alcohol consumption) 6. OSA with uncontrolled or untreated cardiovascular disease 7. Central Sleep Apnoea events (greater than or equal to 5/hr) 8. Previous Uvulopalatopharyngoplasty (UPPP) 9. Severe somatic or psychiatric disorders 10. Periodic limb disorder 11. Reversible morphological upper airway abnormalities e.g. enlarged tonsils 12. Temporomandibular disorders 13. Dental pain
Outcome results
None listed