title: Effects of testosterone therapy on sleep and breathing in obese men with severe obstructive sleep apnoea: a randomized placebo-controlled trial.
abstract: OBJECTIVE
  High doses of short-term testosterone have been shown to acutely worsen sleep-disordered breathing in men with obstructive sleep apnoea (OSA). The effects of lower, near-conventional doses of testosterone in obese men with OSA may differ over the longer term but have not been systematically studied. We assessed sleep and breathing effects of near-conventional testosterone treatment as an adjunct to weight loss in obese men with severe OSA.
  
  
  METHODS
  An 18-week randomized, double-blind, placebo-controlled, parallel group trial in 67 men.
  
  
  METHODS
  All subjects were placed on a hypocaloric diet and then received intramuscular injections of 1000 mg testosterone undecanoate or placebo at 0, 6 and 12 weeks.
  
  
  RESULTS
  Sleep and breathing were measured by nocturnal polysomnography at 0, 7 and 18 weeks. Testosterone, compared to placebo, worsened the oxygen desaturation index (ODI) by 10·3 events/h (95%CI, 0·8-19·8 events/h; P = 0·03) and nocturnal hypoxaemia (sleep time with oxygen saturation <90%, SpO(2) T90%) by 6·1% (95%CI, 1·5-10·6; P = 0·01) at 7 weeks. Testosterone therapy did not alter ODI (4·5, -5·4 to 14·4 events/h; P = 0·36) or SpO(2) T90% at 18 weeks (2·9, -1·9-7·7%; P = 0·23) compared to placebo. The testosterone treatment effects on ODI and SpO(2) T90% were not influenced by baseline testosterone concentrations (testosterone by treatment interactions, all P > 0·35). Blood testosterone concentrations did not correlate with ODI or SpO(2) T90% (all P > 0·19).
  
  
  CONCLUSIONS
  Testosterone therapy in obese men with severe OSA mildly worsens sleep-disordered breathing in a time-limited manner, irrespective of initial testosterone concentrations. This time-dependency was not related to testosterone concentrations.
  
  
  BACKGROUND
  www.anzctr.org.au Identifier: ACTRN1260-6000404527.
authors.affiliation: Endocrine and Cardiometabolic Research Group, NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.
authors.forename: Camilla M
authors.initials: CM
authors.lastname: Hoyos
authors.forename: Roo
authors.initials: R
authors.lastname: Killick
authors.forename: Brendon J
authors.initials: BJ
authors.lastname: Yee
authors.forename: Ronald R
authors.initials: RR
authors.lastname: Grunstein
authors.forename: Peter Y
authors.initials: PY
authors.lastname: Liu
mesh_terms: D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000503:physiopathology*; D012119:Respiration / Q000187:drug effects*; D012890:Sleep / Q000187:drug effects*; D020181:Sleep Apnea, Obstructive / Q000188:drug therapy* / Q000503:physiopathology*; D013739:Testosterone / Q000627:therapeutic use*
chemical_list: D013739:Testosterone