None listed
Conditions
Brief summary
The broad aim of the project is to compare MAS and CPAP treatment in patients with Obstructive Sleep Apnoea to test the hypothesis that these treatments have equivalent health effects in terms of important clinical outcomes as a result of the superior efficacy of CPAP being offset by lower treatment compliance than MAS.
Interventions
The study will compare the gold standard treatment for Obstructive Sleep Apnoea, namely Continuous Positive Airway Pressure (CPAP), to oral appliance therapy. CPAP treatment involves the delivery of pressurised air from a pump to the nose via tubing and a nose mask. The pressurised air acts to prevent the airway from collapsing during sleep. Oral appliance therapy involves a titratable intra-oral device worn during sleep, that advances the mandible to improve upper airway calibre and function.
The study will compare the gold standard treatment for Obstructive Sleep Apnoea, namely Continuous Positive Airway Pressure (CPAP), to oral appliance therapy. CPAP treatment involves the delivery of pressurised air from a pump to the nose via tubing and a nose mask. The pressurised air acts to prevent the airway from collapsing during sleep. Oral appliance therapy involves a titratable intra-oral device worn during sleep, that advances the mandible to improve upper airway calibre and function. The oral appliance being used is a Mandibular Advancement Splint (MAS). Following appropriate acclimatisation to both treatment modalities, patients will undergo 1 month intervention with each treatment (cross-over design) in order to compare the health effects of the treatments. Subjects will be encouraged to use each device every night during sleep. Following treatment on the first device, there will be a 2 week washout period before subjects are crossed over to the second device.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Presence of at least 2 symptoms of obstructive sleep apnoea (snoring, fragmented sleep, witnessed apneas, daytime sleepiness); proven obstructive sleep apnoea on polysomnography (AHI>10)
Exclusion criteria
Previous treatment of Obstuctive Sleep Apnoea; central sleep apnea, need for immediate treatment, co-existing sleep disorder, contraindications to oral appliance therapy, regular use of sedatives or narcotics, pre-existing lung disease, active psychiatric disease
Outcome results
None listed