Daulatzai MA Evidence of neurodegeneration in obstructive sleep apnea: Relationship between obstructive sleep apnea and cognitive dysfunction in the elderly. J Neurosci Res. 2015 Dec;93(12):1778-94. doi: 10.1002/jnr.23634. Epub 2015 Aug 24.
Horvath A, Szucs A, Barcs G, Kamondi A Sleep EEG Detects Epileptiform Activity in Alzheimer's Disease with High Sensitivity. J Alzheimers Dis. 2017;56(3):1175-1183. doi: 10.3233/JAD-160994.
Lim AS, Kowgier M, Yu L, Buchman AS, Bennett DA Sleep Fragmentation and the Risk of Incident Alzheimer's Disease and Cognitive Decline in Older Persons. Sleep. 2013 Jul 1;36(7):1027-1032. doi: 10.5665/sleep.2802.
Lim AS, Yu L, Kowgier M, Schneider JA, Buchman AS, Bennett DA Modification of the relationship of the apolipoprotein E epsilon4 allele to the risk of Alzheimer disease and neurofibrillary tangle density by sleep. JAMA Neurol. 2013 Dec;70(12):1544-51. doi: 10.1001/jamaneurol.2013.4215.
Lim MM, Gerstner JR, Holtzman DM The sleep-wake cycle and Alzheimer's disease: what do we know? Neurodegener Dis Manag. 2014;4(5):351-62. doi: 10.2217/nmt.14.33.
Malow A, Bowes RJ, Ross D Relationship of temporal lobe seizures to sleep and arousal: a combined scalp-intracranial electrode study. Sleep. 2000 Mar 15;23(2):231-4.
Manni R, Terzaghi M Comorbidity between epilepsy and sleep disorders. Epilepsy Res. 2010 Aug;90(3):171-7. doi: 10.1016/j.eplepsyres.2010.05.006. Epub 2010 May 31.
McBride AE, Shih TT, Hirsch LJ Video-EEG monitoring in the elderly: a review of 94 patients. Epilepsia. 2002 Feb;43(2):165-9. doi: 10.1046/j.1528-1157.2002.24401.x.
Musiek ES, Holtzman DM Mechanisms linking circadian clocks, sleep, and neurodegeneration. Science. 2016 Nov 25;354(6315):1004-1008. doi: 10.1126/science.aah4968.
Noebels J A perfect storm: Converging paths of epilepsy and Alzheimer's dementia intersect in the hippocampal formation. Epilepsia. 2011 Jan;52 Suppl 1(Suppl 1):39-46. doi: 10.1111/j.1528-1167.2010.02909.x.
Ooms S, Overeem S, Besse K, Rikkert MO, Verbeek M, Claassen JA Effect of 1 night of total sleep deprivation on cerebrospinal fluid beta-amyloid 42 in healthy middle-aged men: a randomized clinical trial. JAMA Neurol. 2014 Aug;71(8):971-7. doi: 10.1001/jamaneurol.2014.1173.
Slats D, Claassen JA, Lammers GJ, Melis RJ, Verbeek MM, Overeem S Association between hypocretin-1 and amyloid-beta42 cerebrospinal fluid levels in Alzheimer's disease and healthy controls. Curr Alzheimer Res. 2012 Dec;9(10):1119-25. doi: 10.2174/156720512804142840.
van Golde EG, Gutter T, de Weerd AW Sleep disturbances in people with epilepsy; prevalence, impact and treatment. Sleep Med Rev. 2011 Dec;15(6):357-68. doi: 10.1016/j.smrv.2011.01.002. Epub 2011 Mar 24.
Volicer L, Smith S, Volicer BJ Effect of seizures on progression of dementia of the Alzheimer type. Dementia. 1995 Sep-Oct;6(5):258-63. doi: 10.1159/000106956.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.