Impact on upper airway mechanics of a built in oral appliance airway in patients with obstructive sleep apnoea.
- Conditions
- obstructive sleep apnoeaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12616001324404
- Lead Sponsor
- Oventus Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 22
1.Age > 18 years old < 75
2.Obstructive sleep apnoea as diagnosed by polysomnography
a.In the last 2 years
b.> 2 years and < 5 years from diagnosis if BMI and general health stable since diagnosis
3.Already using an oral appliance for the treatment of OSA at least 5 nights per week
4.Able to sleep in the supine position
5.Able to provide written informed consent to all study procedures, investigators to access clinical records from treating physician and agrees to adhere to all protocol requirements.
To continue on to Part 2, subjects must demonstrate the following from Part 1
1.Supine AHI >15 and <60
2.Total sleep time > 4 hours
3.Demonstrated tolerance to instrumentation with more than 3 hours of supine sleep time with pharyngeal catheter and partitioned mask.
1.Pregnant or lactating females
2.Participating in another interventional clinical trial
3.Primary snoring
4.Uncontrolled or untreated cardiovascular disease
5.Central Sleep Apnoea events (greater than or equal to 5/hr)
6.Periodic limb disorder
7.Previous Uvulopalatopharyngoplasty (UPPP)
8.Medication usage that could influence respiration or sleep (e.g. regular use of sedatives, heavy alcohol consumption)
9.Severe somatic or psychiatric disorders
10.Periodontal disease, temporomandibular disorder or dental pain that would prevent ongoing suitability for an oral appliance
11.Unable or unwilling to sleep with full face mask
12.Strong gag reflex
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method