Sleep Initiation and Maintenance Disorders: Anonymous00077

Kezirian EJ, Harrison SL, Ancoli-Israel S, Redline S, Ensrud K, Goldberg AN, Claman DM, Spira AP, Stone KL, Anonymous00077. · Department of Otolaryngology--Head and Neck Surgery, University of California, San Francisco, San Francisco, California, USA. · Sleep. · Pubmed #19238813 links to  free full text

Abstract: STUDY OBJECTIVES: To examine the association between sleep-disordered breathing (SDB) and subjective measures of daytime sleepiness, sleep quality, and sleep-related quality of life in a large cohort of community-dwelling older men and to determine whether any association remained after adjustment for sleep duration. DESIGN: Cross-sectional. The functional outcome measures of interest were daytime sleepiness (Epworth Sleepiness Scale, ESS), sleep-related symptoms (Pittsburgh Sleep Quality Index, PSQI), and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ). Analysis of variance and adjusted regression analyses examined the association between these outcome measures and SDB severity and actigraphy-determined total sleep time (TST). We then explored whether associations with SDB were confounded by sleep duration by adjusting models for TST. SETTING: Community-based sample in home and research clinic settings. PARTICIPANTS: Two-thousand eight-hundred forty-nine older men from the multicenter Osteoporotic Fractures in Men Study that began in 2000. All participants underwent in-home polysomnography for 1 night and wrist actigraphy for a minimum of 5 consecutive nights. INTERVENTIONS: N/A. Measurements and Results: Participants were aged 76.4 + 5.5 years and had an apnea-hypopnea index (AHI) of 17.0 + 15.0. AHI and TST were weakly correlated. ESS scores individually were modestly associated with AHI and TST, but the association with AHI was attenuated by adjustment for TST. PSQI and FOSQ scores were largely not associated with measures of SDB severity but were modestly associated with TST. CONCLUSIONS: Daytime sleepiness, nighttime sleep disturbances, and sleep-related quality of life were modestly associated with TST. After adjustment for TST, there was no independent association with SDB severity. These results underscore the potential differences in SDB functional outcomes in older versus young and middle-aged adults.

Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW, Anonymous00077. · Stanford University Center of Excellence for Sleep Disorders, Stanford, CA 94305-5730, USA. · Neurology. · Pubmed #19188575 No free full text.

Abstract: OBJECTIVE: To assess the efficacy and tolerability of the nondopaminergic agent XP13512/GSK1838262 in adults with moderate to severe primary restless legs syndrome (RLS). METHODS: Patient Improvements in Vital Outcomes following Treatment in Restless Legs Syndrome I was a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of XP13512 1,200 mg or placebo taken once daily at 5:00 pm with food. Coprimary endpoints were mean change from baseline International Restless Legs Scale (IRLS) total score and proportion of investigator-rated responders (very much improved or much improved on the Clinical Global Impression-Improvement scale) at week 12 (last observation carried forward). Tolerability was assessed using adverse events, vital signs, and clinical laboratory parameters. RESULTS: A total of 222 patients were randomized (XP13512 = 114, placebo = 108) and 192 patients (XP13512 = 100, placebo = 92) completed the study. At week 12, the mean change from baseline IRLS total score was greater with XP13512 (-13.2) compared with placebo (-8.8). Analysis of covariance, adjusted for baseline score and pooled site, demonstrated a mean treatment difference of -4.0 (95% confidence interval [CI], -6.2 to -1.9; p = 0.0003). More patients treated with XP13512 (76.1%) were responders compared with placebo (38.9%; adjusted OR 5.1; 95% CI, 2.8 to 9.2; p < 0.0001). Significant treatment effects for both coprimary measures were identified at week 1, the earliest time point measured. The most commonly reported adverse events were somnolence (XP13512 27%, placebo 7%) and dizziness (XP13512 20%, placebo 5%), which were mild to moderate in intensity and generally remitted. CONCLUSIONS: XP13512 1,200 mg, taken once daily, significantly improved restless legs syndrome (RLS) symptoms compared with placebo and was generally well tolerated in adults with moderate to severe primary RLS.