David F Dinges1, Terri E Weaver. 1. Division of Sleep and Chronobiology, Department of Psychiatry, and Center for Sleep and Respiratory Neurobiology, University of Pennsylvania School of Medicine, 1013 Blockley Hall, Philadelphia, PA 19104-6021, USA. dinges@mail.med.upenn.edu
Abstract
BACKGROUND: Some patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who are regular users ofnasal continuous positive airway pressure (nCPAP) therapy continue to experience daytime sleepiness that impairs performance and quality of life. A randomized, double-blind, placebo-controlled, parallel-group study was conducted to determine the effect of modafinil on sustained attention performance and functional quality of life in OSA/HS patients with residual daytime sleepiness, who were regular users of nCPAP therapy. METHODS: Seventy-seven patients received modafinil (200 mg/day, week 1; 400 mg/day, weeks 2-4) and 80 patients received matching placebo once daily for 4 weeks. Sustained attention performance on the psychomotor vigilance task (PVT) and functional status and quality of life using the Functional Outcomes of Sleep Questionnaire (FOSQ) were measured. RESULTS: The frequency of lapses of attention during PVT performance was significantly decreased, and both the median and slowest reaction times were significantly improved in patients receiving nCPAPplus modafinil compared with those receiving nCPAP plus placebo (P=0.010 for the number of lapses [transformed], P=0.023 for the median reaction time, and P=0.014 for the reciprocal of the 10% slowest reaction times). Treatment with nCPAPplus modafinil significantly improved the FOSQ total score (weeks 1 and 4), the vigilance subscale score (weeks 1 and 4), and the activity level subscale score (week 4) compared with treatment with nCPAP plus placebo (all P<0.05). CONCLUSIONS: Consistent with previous results for objective and subjective measures of sleepiness, modafinil used adjunctively improved performance on a test of behavioral alertness and reduced functional impairments in patients with OSA/HS who were regular users ofnCPAP therapy but still experiencing sleepiness.
RCT Entities:
BACKGROUND: Some patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who are regular users of nasal continuous positive airway pressure (nCPAP) therapy continue to experience daytime sleepiness that impairs performance and quality of life. A randomized, double-blind, placebo-controlled, parallel-group study was conducted to determine the effect of modafinil on sustained attention performance and functional quality of life in OSA/HS patients with residual daytime sleepiness, who were regular users of nCPAP therapy. METHODS: Seventy-seven patients received modafinil (200 mg/day, week 1; 400 mg/day, weeks 2-4) and 80 patients received matching placebo once daily for 4 weeks. Sustained attention performance on the psychomotor vigilance task (PVT) and functional status and quality of life using the Functional Outcomes of Sleep Questionnaire (FOSQ) were measured. RESULTS: The frequency of lapses of attention during PVT performance was significantly decreased, and both the median and slowest reaction times were significantly improved in patients receiving nCPAP plus modafinil compared with those receiving nCPAP plus placebo (P=0.010 for the number of lapses [transformed], P=0.023 for the median reaction time, and P=0.014 for the reciprocal of the 10% slowest reaction times). Treatment with nCPAP plus modafinil significantly improved the FOSQ total score (weeks 1 and 4), the vigilance subscale score (weeks 1 and 4), and the activity level subscale score (week 4) compared with treatment with nCPAP plus placebo (all P<0.05). CONCLUSIONS: Consistent with previous results for objective and subjective measures of sleepiness, modafinil used adjunctively improved performance on a test of behavioral alertness and reduced functional impairments in patients with OSA/HS who were regular users of nCPAP therapy but still experiencing sleepiness.
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