title: Modafinil improves functional outcomes in patients with residual excessive sleepiness associated with CPAP treatment.
abstract: OBJECTIVE
  The objective of this secondary analysis was to examine the effects of modafinil on the Functional Outcomes of Sleep Questionnaire (FOSQ) in patients with obstructive sleep apnea and residual excessive sleepiness with continuous positive airway pressure (CPAP) use. We also explored the association of improvement of functional status with the presenting level of subjective sleepiness.
  
  
  METHODS
  Data were pooled from 2 randomized placebo-controlled studies (4-week and 12-week interventions) of modafinil in patients with residual sleepiness (Epworth Sleepiness Scale score > or =10 on CPAP).
  
  
  RESULTS
  The analysis included 480 patients (FOSQ efficacy data n=442 patients), 292 in the modafinil group and 188 in the placebo group. The mean age (SD) of the analyzed sample was 49.7 (9.2) years; 76% were men. Following administration with modafinil, there were greater improvements from baseline in the Total score (p < 0.0001) as well as 4 of the 5 domains (p < 0.05), compared with placebo. A greater proportion of patients who received modafinil were considered responders, compared with patients who received placebo (45% vs. 25%; p < 0.001). Responder analysis based on the individual FOSQ domain items demonstrated that 18 of the 30 FOSQ items increased by at least 1 point for significantly more patients who received modafinil (p < 0.05). Improvements in functional status were not found to depend on patients' degree of subjective sleepiness at baseline.
  
  
  CONCLUSIONS
  In this secondary analysis of data from patients with OSA and excessive sleepiness despite CPAP use, modafinil was associated with improvements in patients' functional outcomes and their ability to engage in a broad array of everyday activities.
authors.affiliation: Biobehavioral and Health Sciences Division, School of Nursing, Center for Sleep and Respiratory Neurobiology, University of Pennsylvania, Philadelphia, PA 19104-6096, USA. tew@nursing.upenn.edu
authors.forename: Terri E
authors.initials: TE
authors.lastname: Weaver
authors.forename: Eileen R
authors.initials: ER
authors.lastname: Chasens
authors.forename: Sanjay
authors.initials: S
authors.lastname: Arora
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects / Q000379:methods*; D006970:Disorders of Excessive Somnolence / Q000150:complications / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011788:Quality of Life; D020181:Sleep Apnea, Obstructive / Q000150:complications / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects; D055815:Young Adult
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil
references.citation: Electroencephalogr Clin Neurophysiol. 1982 Jun;53(6):658-61
references.pmid: 6177511
references.citation: Eur Respir J. 2000 Apr;15(4):676-81
references.pmid: 10780758
references.citation: Med Clin (Barc). 1999 Sep 11;113(7):250-5
references.pmid: 10544379
references.citation: Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):211-20
references.pmid: 12853012
references.citation: Thorax. 2006 May;61(5):430-4
references.pmid: 16467072
references.citation: Sleep. 1991 Dec;14(6):540-5
references.pmid: 1798888
references.citation: J Clin Sleep Med. 2006 Apr 15;2(2):193-200
references.pmid: 17557495
references.citation: Am J Respir Crit Care Med. 2001 Dec 1;164(11):2031-5
references.pmid: 11739131
references.citation: Chest. 2003 Dec;124(6):2192-9
references.pmid: 14665500
references.citation: Sleep Med. 2006 Oct;7(7):553-60
references.pmid: 16740408
references.citation: Sleep. 2006 Mar;29(3):381-401
references.pmid: 16553025
references.citation: J Sleep Res. 2000 Mar;9(1):5-11
references.pmid: 10733683
references.citation: Sleep. 2006 Dec;29(12):1521-30
references.pmid: 17252882
references.citation: Am J Respir Crit Care Med. 2001 Feb;163(2):344-8
references.pmid: 11179104
references.citation: Sleep. 1999 Sep 15;22(6):757-65
references.pmid: 10505821
references.citation: Sleep. 2007 Jun;30(6):711-9
references.pmid: 17580592
references.citation: Lancet. 2005 Mar 19-25;365(9464):1046-53
references.pmid: 15781100
references.citation: Lancet. 1999 Jun 19;353(9170):2100-5
references.pmid: 10382693
references.citation: N Engl J Med. 1993 Apr 29;328(17):1230-5
references.pmid: 8464434
references.citation: JAMA. 2000 Apr 12;283(14):1829-36
references.pmid: 10770144
references.citation: Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001106
references.pmid: 16855960
references.citation: Am J Respir Crit Care Med. 2007 Nov 15;176(10):954-6
references.pmid: 17823357
references.citation: Sleep Med. 2003 Sep;4(5):393-402
references.pmid: 14592280
references.citation: N Engl J Med. 2000 May 11;342(19):1378-84
references.pmid: 10805822
references.citation: Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39
references.pmid: 11991871
references.citation: Sleep. 2004 Feb 1;27(1):11-2
references.pmid: 14998230
references.citation: N Engl J Med. 1999 Mar 18;340(11):847-51
references.pmid: 10080847
references.citation: Thorax. 2000 Mar;55(3):224-31
references.pmid: 10679542
references.citation: Chest. 2008 Feb;133(2):496-506
references.pmid: 18252916
references.citation: N Engl J Med. 2005 Nov 10;353(19):2034-41
references.pmid: 16282178
references.citation: Sleep Med Rev. 2007 Jun;11(3):195-207
references.pmid: 17467312
references.citation: Sleep. 2005 Apr;28(4):464-71
references.pmid: 16171291
references.citation: Proc Natl Acad Sci U S A. 1996 Nov 26;93(24):14128-33
references.pmid: 8943072
references.citation: Sleep. 1997 Oct;20(10):835-43
references.pmid: 9415942
references.citation: Scand J Work Environ Health. 2000 Jun;26(3):237-42
references.pmid: 10901116
references.citation: Am J Respir Crit Care Med. 2001 Nov 1;164(9):1675-81
references.pmid: 11719309
references.citation: Am J Respir Crit Care Med. 2001 Mar;163(4):918-23
references.pmid: 11282766
references.citation: Ann Clin Psychiatry. 2004 Apr-Jun;16(2):101-9
references.pmid: 15328903
references.citation: WMJ. 2003;102(1):36-43
references.pmid: 12679970
references.citation: Clin Chest Med. 2003 Jun;24(2):249-59
references.pmid: 12800782
references.citation: Arch Intern Med. 1997 Aug 11-25;157(15):1746-52
references.pmid: 9250236