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Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea.

Roth T, Rippon GA, Arora S - Sleep Breath (2008)

Bottom Line: Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night).Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA.Armodafinil also reduced patient-reported fatigue and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Hospital, Detroit, MI 48202, USA. Troth1@hfhs.org

ABSTRACT
Residual excessive sleepiness (ES) and impaired cognition can occur despite effective and regular nasal continuous positive airway pressure (nCPAP) therapy in some patients with obstructive sleep apnea (OSA). A pooled analysis of two 12-week, randomized, double-blind studies in nCPAP-adherent patients with ES associated with OSA evaluated the effect of armodafinil on wakefulness and cognition. Three hundred and ninety-one patients received armodafinil (150 or 250 mg) and 260 patients received placebo once daily for 12 weeks. Efficacy assessments included the Maintenance of Wakefulness Test (MWT), Cognitive Drug Research cognitive performance battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory. Adverse events were monitored. Armodafinil increased mean MWT sleep latency from baseline to final visit by 2.0 min vs a decrease of 1.5 min with placebo (P < 0.0001). Compared with placebo, armodafinil significantly improved quality of episodic secondary memory (P < 0.05) and patients' ability to engage in activities of daily living (P < 0.0001) and reduced fatigue (P < 0.01). The most common adverse events were headache, nausea, and insomnia. Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night). Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA. Armodafinil also reduced patient-reported fatigue and was well tolerated.

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Related in: MedlinePlus

Mean (SEM) change from baseline in fatigue. a Global fatigue. b Worst fatigue in the past 24 h. BFI Brief Fatigue Inventory
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Fig5: Mean (SEM) change from baseline in fatigue. a Global fatigue. b Worst fatigue in the past 24 h. BFI Brief Fatigue Inventory

Mentions: The mean (SD) scores for global fatigue from the BFI at baseline were 4.8 (1.9) and 4.9 (1.9) for the armodafinil and placebo groups, respectively. Armodafinil significantly improved global fatigue at all visits compared with placebo (P < 0.01; Fig. 5a). Mean scores for worst fatigue in the past 24 h from the BFI at baseline were nearly identical for the armodafinil and placebo groups (7.2 [2.0] and 7.3 [2.0], respectively) and indicated severe fatigue (score greater than or equal to 7). Armodafinil significantly improved scores for worst fatigue in the past 24 h at weeks 4 and 12 and at the final visit (P < 0.05 vs placebo; Fig. 5b), with a trend toward significance at week 8 (P = 0.056 vs placebo).Fig. 5


Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea.

Roth T, Rippon GA, Arora S - Sleep Breath (2008)

Mean (SEM) change from baseline in fatigue. a Global fatigue. b Worst fatigue in the past 24 h. BFI Brief Fatigue Inventory
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2194800&req=5

Fig5: Mean (SEM) change from baseline in fatigue. a Global fatigue. b Worst fatigue in the past 24 h. BFI Brief Fatigue Inventory
Mentions: The mean (SD) scores for global fatigue from the BFI at baseline were 4.8 (1.9) and 4.9 (1.9) for the armodafinil and placebo groups, respectively. Armodafinil significantly improved global fatigue at all visits compared with placebo (P < 0.01; Fig. 5a). Mean scores for worst fatigue in the past 24 h from the BFI at baseline were nearly identical for the armodafinil and placebo groups (7.2 [2.0] and 7.3 [2.0], respectively) and indicated severe fatigue (score greater than or equal to 7). Armodafinil significantly improved scores for worst fatigue in the past 24 h at weeks 4 and 12 and at the final visit (P < 0.05 vs placebo; Fig. 5b), with a trend toward significance at week 8 (P = 0.056 vs placebo).Fig. 5

Bottom Line: Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night).Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA.Armodafinil also reduced patient-reported fatigue and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Hospital, Detroit, MI 48202, USA. Troth1@hfhs.org

ABSTRACT
Residual excessive sleepiness (ES) and impaired cognition can occur despite effective and regular nasal continuous positive airway pressure (nCPAP) therapy in some patients with obstructive sleep apnea (OSA). A pooled analysis of two 12-week, randomized, double-blind studies in nCPAP-adherent patients with ES associated with OSA evaluated the effect of armodafinil on wakefulness and cognition. Three hundred and ninety-one patients received armodafinil (150 or 250 mg) and 260 patients received placebo once daily for 12 weeks. Efficacy assessments included the Maintenance of Wakefulness Test (MWT), Cognitive Drug Research cognitive performance battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory. Adverse events were monitored. Armodafinil increased mean MWT sleep latency from baseline to final visit by 2.0 min vs a decrease of 1.5 min with placebo (P < 0.0001). Compared with placebo, armodafinil significantly improved quality of episodic secondary memory (P < 0.05) and patients' ability to engage in activities of daily living (P < 0.0001) and reduced fatigue (P < 0.01). The most common adverse events were headache, nausea, and insomnia. Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night). Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA. Armodafinil also reduced patient-reported fatigue and was well tolerated.

Show MeSH
Related in: MedlinePlus