title: Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea.
abstract: BACKGROUND
  Home portable monitor testing is increasingly being used to diagnose patients with obstructive sleep apnea (OSA) and to initiate them on continuous positive airway pressure (CPAP) treatment.
  
  
  OBJECTIVE
  To compare functional outcome and treatment adherence in patients who receive ambulatory versus in-laboratory testing for OSA.
  
  
  METHODS
  Veterans with suspected OSA were randomized to either home testing or standard in-laboratory testing. Home testing consisted of a type 3 portable monitor recording followed by at least three nights using an automatically adjusting positive airway pressure apparatus. Participants diagnosed with OSA were treated with CPAP for 3 months.
  
  
  RESULTS
  We measured the change in Functional Outcomes of Sleep Questionnaire score, with an a priori noninferiority delta of -1, and the mean daily hours of objectively measured CPAP adherence, with an a priori noninferiority delta of -0.75 hour/day. Of the 296 subjects enrolled, 260 (88%) were diagnosed with OSA, and 213 (75%) were initiated on CPAP. Mean ± SD functional outcome score improved 1.74 ± 2.81 in the home group (P < 0.001) and 1.85 ± 2.46 in the in-laboratory group (P < 0.0001). The lower bound of the one-sided 95% noninferiority confidence interval was -0.54. Mean ± SD hours of daily CPAP adherence were 3.5 ± 2.5 hours/day in the home group and 2.9 ± 2.3 hours/day in the in-laboratory group (P = 0.08). The lower bound of the one-sided 95% noninferiority confidence interval was 0.03.
  
  
  CONCLUSIONS
  Functional outcome and treatment adherence in patients evaluated according to a home testing algorithm is not clinically inferior to that in patients receiving standard in-laboratory polysomnography.
authors.affiliation: VISN 4 Eastern Regional Sleep Center (111P), Department of Medicine, Philadelphia Veterans Affairs Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104, USA.. Samuel.Kuna@va.gov
authors.forename: Samuel T
authors.initials: ST
authors.lastname: Kuna
authors.forename: Indira
authors.initials: I
authors.lastname: Gurubhagavatula
authors.forename: Greg
authors.initials: G
authors.lastname: Maislin
authors.forename: Sakhena
authors.initials: S
authors.lastname: Hin
authors.forename: Kathryn C
authors.initials: KC
authors.lastname: Hartwig
authors.forename: Sue
authors.initials: S
authors.lastname: McCloskey
authors.forename: Robert
authors.initials: R
authors.lastname: Hachadoorian
authors.forename: Sharon
authors.initials: S
authors.lastname: Hurley
authors.forename: Rajesh
authors.initials: R
authors.lastname: Gupta
authors.forename: Bethany
authors.initials: B
authors.lastname: Staley
authors.forename: Charles W
authors.initials: CW
authors.lastname: Atwood
mesh_terms: D000704:Analysis of Variance; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000379:methods*; D010349:Patient Compliance; D015143:Philadelphia; D017286:Polysomnography / Q000379:methods; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis* / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome