期刊论文详细信息
Trials
Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial
Barbara C van Munster5  Sophia E de Rooij3  Hans L Hamburger2  Ingeborg MJA Kuper4  Joke HM Tulen6  Linda R Tulner4  Lotty Hooft1  Esther MM van de Glind1 
[1] Dutch Cochrane Centre, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Clinical Neurophysiology and Amsterdam Center for Sleep-Wake Disorders, Slotervaart Hospital, Amsterdam, the Netherlands;Department of Internal Medicine, Geriatrics Section, Academic Medical Center, P.O. Box 22660, Amsterdam, 1100 DD, The Netherlands;Department of Geriatric Medicine, Slotervaart Hospital, Amsterdam, The Netherlands;Department of Geriatric Medicine, Gelre Hospitals, Apeldoorn, The Netherlands;Department of Psychiatry, Erasmus MC, Rotterdam, The Netherlands
关键词: Sleep;    RCT;    Protocol;    Geriatrics;    Acetaminophen;   
Others  :  807696
DOI  :  10.1186/1745-6215-15-10
 received in 2012-11-30, accepted in 2013-12-13,  发布年份 2014
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【 摘 要 】

Background

The prevalence of sleep disorders increases with age. Sleep disorders may have serious health implications and may be related to serious underlying diseases. Many older people use hypnotics, like benzodiazepines, although these medications have serious side effects and often lead to habituation. Acetaminophen is one of the most frequently used off-label drugs for sleep disorders, although little is known about its effects. Our objective is to investigate whether acetaminophen is effective in treating self-reported sleep disorders in older people.

Methods/Design

Participants, aged 65 years or older (n = 150), who have sleep disorders will be randomized for treatment with either acetaminophen 1000 mg or placebo, once daily at bedtime in a double-blind design. Eligible patients should be able to give informed consent, should not be cognitively impaired (Minimal Mental State Examination (MMSE) score ≥ 20), should not have pain, and should not use acetaminophen on a regular basis because of pain complaints. The study will take three weeks to complete. During these three weeks, the participants register their sleep behavior in a sleep diary. The participants will use the study medication during the second and third week. The primary endpoint will be the self-reported sleep disorders at the end of week three, as measured by means of the Insomnia Severity Index (ISI). To validate these subjective sleep parameters against objectively measured indices of the sleep-wake pattern, we will measure the periods of wakefulness and sleep in a subgroup of participants, using an actigraph worn on the wrist during the entire study period.

Discussion

The proposed study will contribute to our knowledge about the treatment of sleep disorders in an older population. There is a need for treatments for sleep disorders without serious adverse effects. Acetaminophen might be a simple and inexpensive alternative for the regimes that are currently used with older people.

Trial registration

The Netherlands National Trial Register NTR2747.

【 授权许可】

   
2014 van de Glind et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG: Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep 1995, 18(6):425-432.
  • [2]Reid KJ, Martinovich Z, Finkel S, Statsinger J, Golden R, Harter K, Zee PC: Sleep: a marker of physical and mental health in the elderly. Am J Geriatr Psychiatry 2006, 14(10):860-866.
  • [3]Roth T, Ancoli-Israel S: Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. II. Sleep 1999, 22(Suppl 2):S354-S358.
  • [4]Ancoli-Israel S: Sleep and its disorders in aging populations. Sleep Med 2009, 10(Suppl 1):S7-S11.
  • [5]Montgomery P, Dennis J: Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2003, 1:CD003161.
  • [6]Morin CM, Benca R: Chronic insomnia. Lancet 2012, 379(9821):1129-1141.
  • [7]Montgomery P, Dennis J: Bright light therapy for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2002, 2:CD003403.
  • [8]Montgomery P, Dennis J: Physical exercise for sleep problems in adults aged 60+. Cochrane Database Syst Rev 2002, 4:CD003404.
  • [9]Kupfer DJ, Reynolds CF III: Management of insomnia. N Engl J Med 1997, 336(5):341-346.
  • [10]Ancoli-Israel S, Richardson GS, Mangano RM, Jenkins L, Hall P, Jones WS: Long-term use of sedative hypnotics in older patients with insomnia. Sleep Med 2005, 6(2):107-113.
  • [11]Nurmi-Lüthje I, Kaukonen JP, Lüthje P, Naboulsi H, Tanninen S, Kataja M, Kallio ML, Leppilampi M: Use of benzodiazepines and benzodiazepine-related drugs among 223 patients with an acute hip fracture in Finland: comparison of benzodiazepine findings in medical records and laboratory assays. Drugs Aging 2006, 23(1):27-37.
  • [12]Campbell AJ, Robertson MC, Gardner MM, Norton RN, Buchner DM: Psychotropic medication withdrawal and a home-based exercise program to prevent falls: a randomized, controlled trial. J Am Geriatr Soc 1999, 47(7):850-853.
  • [13]Stewart SA: The effects of benzodiazepines on cognition. J Clin Psychiatry 2005, 66(Suppl 2):9-13.
  • [14]O’Brien CP: Benzodiazepine use, abuse, and dependence. J Clin Psychiatry 2005, 66(Suppl 2):28-33.
  • [15]Kripke DF, Langer RD, Kline LE: Hypnotics’ association with mortality or cancer: a matched cohort study. BMJ Open 2012, 2(1):e000850.
  • [16]Sproule BA, Busto UE, Buckle C, Herrmann N, Bowles S: The use of non-prescription sleep products in the elderly. Int J Geriatr Psychiatry 1999, 14(10):851-857.
  • [17]Courade JP, Caussade F, Martin K, Besse D, Delchambre C, Hanoun N, Hamon M, Eschalier A, Cloarec A: Effects of acetaminophen on monoaminergic systems in the rat central nervous system. Naunyn Schmiedebergs Arch Pharmacol 2001, 364(6):534-537.
  • [18]Mallet C, Daulhac L, Bonnefont J, Ledent C, Etienne M, Chapuy E, Libert F, Eschalier A: Endocannabinoid and serotonergic systems are needed for acetaminophen-induced analgesia. Pain 2008, 139(1):190-200.
  • [19]Lack LC, Gradisar M, van Someren EJ, Wright HR, Lushington K: The relationship between insomnia and body temperatures. Sleep Med Rev 2008, 12(4):307-317.
  • [20]Bastien CH, Vallieres A, Morin CM: Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med 2001, 2(4):297-307.
  • [21]Sadeh A: The role and validity of actigraphy in sleep medicine: an update. Sleep Med Rev 2011, 15:259-267.
  • [22]American Psychiatric Association: Diagnostic and Statistical Manual of Mental Health Disorders. Washington DC; 2000. [4th edition, text revision]
  • [23]Buysse DJ, Reynolds CF III, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res 1989, 28(2):193-213.
  • [24]Folstein MF, Folstein SE, McHugh PR: Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12(3):189-198.
  • [25]Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW: Studies of illness in the aged. The index of ADL: a standardized measurement of biological and psychosocial function. JAMA 1963, 185:914-919.
  • [26]Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987, 40(5):373-383.
  • [27]Morin CM: Insomnia. New York: Psychological assessment and management; 1993.
  • [28]Hoekert M, der Lek RF, Swaab DF, Kaufer D, van Someren EJ: Comparison between informant-observed and actigraphic assessments of sleep-wake rhythm disturbances in demented residents of homes for the elderly. Am J Geriatr Psychiatry 2006, 14(2):104-111.
  • [29]Maglione JE, Ancoli-Israel S, Peters KW, Paudel ML, Yaffe K, Ensrud KE, Stone KL: Depressive symptoms and subjective and objective sleep in community-dwelling older women. J Am Geriatr Soc 2012, 60(4):635-643.
  • [30]Walsh JK, Krystal AD, Amato DA, Rubens R, Caron J, Wessel TC, Schaefer K, Roach J, Wallenstein G, Roth T: Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations. Sleep 2007, 30(8):959-968.
  • [31]Mody L, Miller DK, McGloin JM, Freeman M, Marcantonio ER, Magaziner J, Studenski S: Recruitment and retention of older adults in aging research. J Am Geriatr Soc 2008, 56(12):2340-2348.
  • [32]Harris R, Dyson E: Recruitment of frail older people to research: lessons learned through experience. J Adv Nurs 2001, 36:643-651.
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