None listed
Conditions
Interventions
Sixty patients with severe obstructive sleep apnoea (OSA), defined as an apnoea/hypopnoea index greater than 20, will be randomized to best medical care or to Lap-Band placement plus best medical care.
Sponsors
Monash University School of Primary Health Care
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Have a body mass index between 32 and 50kg/m2, able to indicate several genuine attempts top lose significant weight, be recently diagnosed (6-months) with moderate to severe symptomatic obstructive sleep apnoea (AHI>20/hr) and have been advised to use nasal CPAP therapy for treatment (Satisfactory implementation or compliance with CPAP therapy would not be required as an entry criterion), be willing to be randomized into one of the two treatment programs and be able to understand the options, study requirements, and to comply with the requirements of both programs.
Exclusion criteria
Failure to have made at least 3 significant attempts at weight loss, , history of previous abdominal surgery which would potentially preclude laparascopic placement of the band , obesity hypoventilation syndrome requiring BIPAP therapy (i.e. raised CO2 levels) or contraindication to a diagnostic sleep study, history of surgery to the airway for snoring or OSA, finding of a significant upper airway deformity or obstruction that was not obesity related (e.g. enlarged tonsils or nasal obstruction), medical problems which contra-indicate the application of either arm of the study including acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure), sex if gender stratification is necessary due to numbers randomized . Gender stratification may be necessary as approximately equal numbers of men and women will be admitted to the study. If 26 of one gender have been randomly allocated the remaining subjects will be of the opposite gender.
Outcome results
None listed