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Sodium oxybate for excessive daytime sleepiness in Parkinson disease: an open-label polysomnographic study.
Arch Neurol. 2008 Oct; 65(10):1337-40.AN

Abstract

BACKGROUND

Many patients with Parkinson disease (PD) have excessive daytime sleepiness and numerous nocturnal sleep abnormalities.

OBJECTIVE

To determine the safety and efficacy of the controlled drug sodium oxybate in a multicenter, open-label, polysomnographic study in subjects with PD and sleep disorders. Design, Setting, and Patients Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleep-disordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an off-medication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD).

RESULTS

We enrolled 38 subjects. At screening, 8 had sleep apnea (n = 7) or depression (n = 1). Twenty-seven of 30 subjects completed the study. Three dropped out owing to dizziness (n = 3) and concurrent depression (n = 1). The mean dose of sodium oxybate was 7.8 (1.7) g per night. The ESS score improved from 15.6 (4.2) to 9.0 (5.0) (P < .001); the Pittsburgh Sleep Quality Inventory score, from 10.9 (4.0) to 6.6 (3.9) (P < .001); and the Fatigue Severity Scale score, from 42.9 (13.2) to 36.3 (14.3) (P < .001). Mean slow-wave sleep time increased from 41.3 (33.2) to 78.0 (61.2) minutes (P = .005). Changes in off-medication UPDRS scores were not significant, from 28.4 (10.3) to 26.2 (9.6).

CONCLUSION

Nocturnally administered sodium oxybate improved excessive daytime sleepiness and fatigue in PD.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00641186.

Authors+Show Affiliations

Department of Neurology, Baylor College of Medicine, 6550 Fannin, Ste 1801, Houston, TX 77030, USA. wondo@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18852348

Citation

Ondo, William G., et al. "Sodium Oxybate for Excessive Daytime Sleepiness in Parkinson Disease: an Open-label Polysomnographic Study." Archives of Neurology, vol. 65, no. 10, 2008, pp. 1337-40.
Ondo WG, Perkins T, Swick T, et al. Sodium oxybate for excessive daytime sleepiness in Parkinson disease: an open-label polysomnographic study. Arch Neurol. 2008;65(10):1337-40.
Ondo, W. G., Perkins, T., Swick, T., Hull, K. L., Jimenez, J. E., Garris, T. S., & Pardi, D. (2008). Sodium oxybate for excessive daytime sleepiness in Parkinson disease: an open-label polysomnographic study. Archives of Neurology, 65(10), 1337-40. https://doi.org/10.1001/archneur.65.10.1337
Ondo WG, et al. Sodium Oxybate for Excessive Daytime Sleepiness in Parkinson Disease: an Open-label Polysomnographic Study. Arch Neurol. 2008;65(10):1337-40. PubMed PMID: 18852348.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sodium oxybate for excessive daytime sleepiness in Parkinson disease: an open-label polysomnographic study. AU - Ondo,William G, AU - Perkins,Thomas, AU - Swick,Todd, AU - Hull,Keith L,Jr AU - Jimenez,J Ernesto, AU - Garris,Tippy S, AU - Pardi,Daniel, PY - 2008/10/15/pubmed PY - 2008/11/19/medline PY - 2008/10/15/entrez SP - 1337 EP - 40 JF - Archives of neurology JO - Arch Neurol VL - 65 IS - 10 N2 - BACKGROUND: Many patients with Parkinson disease (PD) have excessive daytime sleepiness and numerous nocturnal sleep abnormalities. OBJECTIVE: To determine the safety and efficacy of the controlled drug sodium oxybate in a multicenter, open-label, polysomnographic study in subjects with PD and sleep disorders. Design, Setting, and Patients Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleep-disordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an off-medication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD). RESULTS: We enrolled 38 subjects. At screening, 8 had sleep apnea (n = 7) or depression (n = 1). Twenty-seven of 30 subjects completed the study. Three dropped out owing to dizziness (n = 3) and concurrent depression (n = 1). The mean dose of sodium oxybate was 7.8 (1.7) g per night. The ESS score improved from 15.6 (4.2) to 9.0 (5.0) (P < .001); the Pittsburgh Sleep Quality Inventory score, from 10.9 (4.0) to 6.6 (3.9) (P < .001); and the Fatigue Severity Scale score, from 42.9 (13.2) to 36.3 (14.3) (P < .001). Mean slow-wave sleep time increased from 41.3 (33.2) to 78.0 (61.2) minutes (P = .005). Changes in off-medication UPDRS scores were not significant, from 28.4 (10.3) to 26.2 (9.6). CONCLUSION: Nocturnally administered sodium oxybate improved excessive daytime sleepiness and fatigue in PD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00641186. SN - 1538-3687 UR - https://www.unboundmedicine.com/medline/citation/18852348/Sodium_oxybate_for_excessive_daytime_sleepiness_in_Parkinson_disease:_an_open_label_polysomnographic_study_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/archneur.65.10.1337 DB - PRIME DP - Unbound Medicine ER -