A randomized controlled trial of the effect of substantial weight loss on obstructive sleep apnoea as measured by the apnoea/hypopnoea index.

Monash University School of Primary Health Care0 sites60 target enrollmentAugust 16, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 16, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Monash University School of Primary Health Care

•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.

•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.