Skip to Main Content

Working...

ClinicalTrials.gov Menu

SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03954210

Recruitment Status : Not yet recruiting

First Posted : May 17, 2019

Last Update Posted : July 2, 2019

See Contacts and Locations

Sponsor:

Collaborators:

National Institute on Aging (NIA)

National Institutes of Health (NIH)

Information provided by (Responsible Party):

University of Kansas Medical Center

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Not yet recruiting
Estimated Primary Completion Date :	September 2020
Estimated Study Completion Date :	September 2020

Publications:

Solomon A, Mangialasche F, Richard E, Andrieu S, Bennett DA, Breteler M, Fratiglioni L, Hooshmand B, Khachaturian AS, Schneider LS, Skoog I, Kivipelto M. Advances in the prevention of Alzheimer's disease and dementia. J Intern Med. 2014 Mar;275(3):229-50. doi: 10.1111/joim.12178.

Wang J, Tan L, Yu JT. Prevention Trials in Alzheimer's Disease: Current Status and Future Perspectives. J Alzheimers Dis. 2016;50(4):927-45. doi: 10.3233/JAD-150826. Review.

Bubu OM, Brannick M, Mortimer J, Umasabor-Bubu O, Sebastião YV, Wen Y, Schwartz S, Borenstein AR, Wu Y, Morgan D, Anderson WM. Sleep, Cognitive impairment, and Alzheimer's disease: A Systematic Review and Meta-Analysis. Sleep. 2017 Jan 1;40(1). doi: 10.1093/sleep/zsw032. Review.

Alessi C, Vitiello MV. Insomnia (primary) in older people: non-drug treatments. BMJ Clin Evid. 2015 May 13;2015. pii: 2302.

Lobo A, López-Antón R, de-la-Cámara C, Quintanilla MA, Campayo A, Saz P; ZARADEMP Workgroup. Non-cognitive psychopathological symptoms associated with incident mild cognitive impairment and dementia, Alzheimer's type. Neurotox Res. 2008 Oct;14(2-3):263-72. doi: 10.1007/BF03033815.

Osorio RS, Pirraglia E, Agüera-Ortiz LF, During EH, Sacks H, Ayappa I, Walsleben J, Mooney A, Hussain A, Glodzik L, Frangione B, Martínez-Martín P, de Leon MJ. Greater risk of Alzheimer's disease in older adults with insomnia. J Am Geriatr Soc. 2011 Mar;59(3):559-62. doi: 10.1111/j.1532-5415.2010.03288.x.

Cricco M, Simonsick EM, Foley DJ. The impact of insomnia on cognitive functioning in older adults. J Am Geriatr Soc. 2001 Sep;49(9):1185-9.

Ju YE, Lucey BP, Holtzman DM. Sleep and Alzheimer disease pathology--a bidirectional relationship. Nat Rev Neurol. 2014 Feb;10(2):115-9. doi: 10.1038/nrneurol.2013.269. Epub 2013 Dec 24. Review.

Branger P, Arenaza-Urquijo EM, Tomadesso C, Mézenge F, André C, de Flores R, Mutlu J, de La Sayette V, Eustache F, Chételat G, Rauchs G. Relationships between sleep quality and brain volume, metabolism, and amyloid deposition in late adulthood. Neurobiol Aging. 2016 May;41:107-114. doi: 10.1016/j.neurobiolaging.2016.02.009. Epub 2016 Feb 17.

Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.

Wang MY, Wang SY, Tsai PS. Cognitive behavioural therapy for primary insomnia: a systematic review. J Adv Nurs. 2005 Jun;50(5):553-64. Review.

Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29. Review.

Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841. Review.

Wu JQ, Appleman ER, Salazar RD, Ong JC. Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. JAMA Intern Med. 2015 Sep;175(9):1461-72. doi: 10.1001/jamainternmed.2015.3006.

Diekelmann S, Wilhelm I, Born J. The whats and whens of sleep-dependent memory consolidation. Sleep Med Rev. 2009 Oct;13(5):309-21. doi: 10.1016/j.smrv.2008.08.002. Epub 2009 Feb 28. Review.

CDC. Insufficient sleep is a public health problem. http://www.cdc.gov/features/dssleep/. Accessed 1/29/16.

Hahn EA, Wang HX, Andel R, Fratiglioni L. A change in sleep pattern may predict Alzheimer disease. Am J Geriatr Psychiatry. 2014 Nov;22(11):1262-71. doi: 10.1016/j.jagp.2013.04.015. Epub 2013 Aug 14.

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.

Ju YE, McLeland JS, Toedebusch CD, Xiong C, Fagan AM, Duntley SP, Morris JC, Holtzman DM. Sleep quality and preclinical Alzheimer disease. JAMA Neurol. 2013 May;70(5):587-93. doi: 10.1001/jamaneurol.2013.2334.

Bero AW, Yan P, Roh JH, Cirrito JR, Stewart FR, Raichle ME, Lee JM, Holtzman DM. Neuronal activity regulates the regional vulnerability to amyloid-β deposition. Nat Neurosci. 2011 Jun;14(6):750-6. doi: 10.1038/nn.2801. Epub 2011 May 1.

Varga AW, Wohlleber ME, Giménez S, Romero S, Alonso JF, Ducca EL, Kam K, Lewis C, Tanzi EB, Tweardy S, Kishi A, Parekh A, Fischer E, Gumb T, Alcolea D, Fortea J, Lleó A, Blennow K, Zetterberg H, Mosconi L, Glodzik L, Pirraglia E, Burschtin OE, de Leon MJ, Rapoport DM, Lu SE, Ayappa I, Osorio RS. Reduced Slow-Wave Sleep Is Associated with High Cerebrospinal Fluid Aβ42 Levels in Cognitively Normal Elderly. Sleep. 2016 Nov 1;39(11):2041-2048.

Ohayon MM, Carskadon MA, Guilleminault C, Vitiello MV. Meta-analysis of quantitative sleep parameters from childhood to old age in healthy individuals: developing normative sleep values across the human lifespan. Sleep. 2004 Nov 1;27(7):1255-73.

Merica H, Blois R, Gaillard JM. Spectral characteristics of sleep EEG in chronic insomnia. Eur J Neurosci. 1998 May;10(5):1826-34.

Pigeon WR, Perlis ML. Sleep homeostasis in primary insomnia. Sleep Med Rev. 2006 Aug;10(4):247-54. Epub 2006 Mar 24. Review.

Cervena K, Dauvilliers Y, Espa F, Touchon J, Matousek M, Billiard M, Besset A. Effect of cognitive behavioural therapy for insomnia on sleep architecture and sleep EEG power spectra in psychophysiological insomnia. J Sleep Res. 2004 Dec;13(4):385-93.

Foley D, Monjan A, Masaki K, Ross W, Havlik R, White L, Launer L. Daytime sleepiness is associated with 3-year incident dementia and cognitive decline in older Japanese-American men. J Am Geriatr Soc. 2001 Dec;49(12):1628-32.

Kreutzmann JC, Havekes R, Abel T, Meerlo P. Sleep deprivation and hippocampal vulnerability: changes in neuronal plasticity, neurogenesis and cognitive function. Neuroscience. 2015 Nov 19;309:173-90. doi: 10.1016/j.neuroscience.2015.04.053. Epub 2015 Apr 29. Review.

Mitchell MD, Gehrman P, Perlis M, Umscheid CA. Comparative effectiveness of cognitive behavioral therapy for insomnia: a systematic review. BMC Fam Pract. 2012 May 25;13:40. doi: 10.1186/1471-2296-13-40. Review.

Musiek ES, Xiong DD, Holtzman DM. Sleep, circadian rhythms, and the pathogenesis of Alzheimer disease. Exp Mol Med. 2015 Mar 13;47:e148. doi: 10.1038/emm.2014.121. Review.

Vitiello MV, McCurry SM, Shortreed SM, Balderson BH, Baker LD, Keefe FJ, Rybarczyk BD, Von Korff M. Cognitive-behavioral treatment for comorbid insomnia and osteoarthritis pain in primary care: the lifestyles randomized controlled trial. J Am Geriatr Soc. 2013 Jun;61(6):947-56. doi: 10.1111/jgs.12275. Epub 2013 May 27.

McCurry SM, Shortreed SM, Von Korff M, Balderson BH, Baker LD, Rybarczyk BD, Vitiello MV. Who benefits from CBT for insomnia in primary care? Important patient selection and trial design lessons from longitudinal results of the Lifestyles trial. Sleep. 2014 Feb 1;37(2):299-308. doi: 10.5665/sleep.3402.