Yves Dauvilliers1, Thomas Roth2, Diane Guinta3, Sarah Alvarez-Horine3, Efim Dynin3, Jed Black4. 1. National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, Department of Neurology, Hôpital Gui-de-Chauliac, Inserm U1061, Montpellier, France. Electronic address: ydauvilliers@yahoo.fr. 2. Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI, USA. 3. Jazz Pharmaceuticals, Palo Alto, CA, USA. 4. Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford University Center for Sleep Research and Medicine, Redwood City, CA, USA.
Abstract
OBJECTIVE: To assess the effects of three narcolepsy treatment modalities on sleep stage shifts associated with disrupted nighttime sleep (DNS) using data from a clinical trial. METHODS: Polysomnograms were reviewed from 155 patients (who had these data available at baseline and 8 weeks) of the 278 patients who were randomized toplacebo, 9-g sodium oxybate (SXB)/nightly, 200-600 mg/d modafinil, or SXB + modafinil. Major outcomes of these post hoc analyses, analyzed using analysis of covariance, were change from baseline in number of shifts from Stages N2/3/rapid eye movement (REM) to Stage N1/Wake, and from Stage N1/Wake to REM. Sleep quality was evaluated using the sleep-quality question from the Pittsburgh Sleep Quality Index. RESULTS:SXB alone or in combination with modafinil significantly decreased the number of shifts from Stage N2/3/REM to Stage N1/Wake (p < 0.01); least-squares mean change in number of shifts from baseline was -0.6, -16.5, 1.8, and -13.7 in the placebo, SXB, modafinil and SXB + modafinil groups, respectively. A similar pattern was observed for changes in shifts from REM to Stage N1/Wake and from Stage N1/Wake to REM. Relative to placebo, sleep quality significantly improved with SXB and SXB + modafinil (p ≤ 0.05) but not with modafinil alone. CONCLUSION: These results show that SXB with and without modafinil significantly consolidated sleep and improved patient-reported sleep quality relative to placebo. In contrast, no such effects were observed with modafinil alone, suggesting a specific effect of SXB on DNS in addition to its effect on daytime sleepiness. CLINICALTRIALS. GOV IDENTIFIER: NCT00066170.
RCT Entities:
OBJECTIVE: To assess the effects of three narcolepsy treatment modalities on sleep stage shifts associated with disrupted nighttime sleep (DNS) using data from a clinical trial. METHODS: Polysomnograms were reviewed from 155 patients (who had these data available at baseline and 8 weeks) of the 278 patients who were randomized to placebo, 9-g sodium oxybate (SXB)/nightly, 200-600 mg/d modafinil, or SXB + modafinil. Major outcomes of these post hoc analyses, analyzed using analysis of covariance, were change from baseline in number of shifts from Stages N2/3/rapid eye movement (REM) to Stage N1/Wake, and from Stage N1/Wake to REM. Sleep quality was evaluated using the sleep-quality question from the Pittsburgh Sleep Quality Index. RESULTS:SXB alone or in combination with modafinil significantly decreased the number of shifts from Stage N2/3/REM to Stage N1/Wake (p < 0.01); least-squares mean change in number of shifts from baseline was -0.6, -16.5, 1.8, and -13.7 in the placebo, SXB, modafinil and SXB + modafinil groups, respectively. A similar pattern was observed for changes in shifts from REM to Stage N1/Wake and from Stage N1/Wake to REM. Relative to placebo, sleep quality significantly improved with SXB and SXB + modafinil (p ≤ 0.05) but not with modafinil alone. CONCLUSION: These results show that SXB with and without modafinil significantly consolidated sleep and improved patient-reported sleep quality relative to placebo. In contrast, no such effects were observed with modafinil alone, suggesting a specific effect of SXB on DNS in addition to its effect on daytime sleepiness. CLINICALTRIALS. GOV IDENTIFIER: NCT00066170.
Authors: Kiran Maski; Lynn Marie Trotti; Suresh Kotagal; R Robert Auger; Todd J Swick; James A Rowley; Sarah D Hashmi; Nathaniel F Watson Journal: J Clin Sleep Med Date: 2021-09-01 Impact factor: 4.324
Authors: Aljohara S Almeneessier; Nouf S Alballa; Budoor H Alsalman; Salih Aleissi; Awad H Olaish; Ahmed S BaHammam Journal: Nat Sci Sleep Date: 2019-10-21
Authors: Richard K Bogan; Michael J Thorpy; Yves Dauvilliers; Markku Partinen; Rafael Del Rio Villegas; Nancy Foldvary-Schaefer; Roman Skowronski; Lihua Tang; Franck Skobieranda; Karel Šonka Journal: Sleep Date: 2021-03-12 Impact factor: 5.849