Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia

References

• Biering-Sørensen F, Biering-Sørensen M, Hilden J. Reproducibility of nordic sleep questionnaire in spinal cord injury. Paraplegia 1994;32(11):780–6.
   PubMedGoogle Scholar
• Biering-Sørensen F, Biering-Sørensen M. Sleep disturbances in the spinal cord injured: an epidemiological questionnaire investigation, including a normal population. Spinal Cord 2001;39(10):505–13.
   PubMed Web of Science ®Google Scholar
• Levi R, Hultling C, Nash MS, Seiger Å. The Stockholm spinal cord injury study: 1. Medical problems in a regional SCI population. Paraplegia 1995;33(6):308–15.
   PubMedGoogle Scholar
• Hyppä MT, Kronholm E. Quality of sleep and chronic illness. J Clin Epidemiol 1989;42(7):633–8.
   PubMed Web of Science ®Google Scholar
• Leger D, Scheuermaier K, Philip P, Paillard M, Guilleminault C. SF-36: evaluation of quality of life in severe and mild insomniacs compared with good sleepers. Psychosom Med 2001;63(1):49–55.
   PubMed Web of Science ®Google Scholar
• Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev 2003;7(4):335–49.
   PubMed Web of Science ®Google Scholar
• Institute of Medicine. Sleep disorders and sleep deprivation. Washington DC: National Academies Press; 2006.
   Google Scholar
• McEvoy RD, Mykytyn I, Sajkov D, Flavell H, Marshall R, Antic R, et al. Sleep apnoea in patients with quadriplegia. Thorax 1995;50(6):613–9.
   PubMed Web of Science ®Google Scholar
• Stockhammer E, Tobon A, Michel F, Eser P, Scheuler W, Bauer W, et al. Characteristics of sleep apnea syndrome in tetraplegic patients. Spinal Cord 2002;40(6):286–94.
   PubMed Web of Science ®Google Scholar
• Buysse DJ, Reynolds CF, III. Insomnia. In: Thorpy MJ (ed.) Handbook of sleep disorders. New York: Marcel Dekker Inc.; 1990. p. 375–404.
   Google Scholar
• Short DJ, Stradling JR, Williams SJ. Prevalence of sleep apnoea in patients over 40 years of age with spinal cord lesions. J Neurol Neurosurg Psychiatry 1992;55(11):1032–6.
   PubMed Web of Science ®Google Scholar
• Cahan C, Gothe B, Decker MJ, Arnold JL, Strohl KP. Arterial oxygen saturation over time and sleep studies in quadriplegic patients. Paraplegia 1993;31(3):172–9.
   PubMedGoogle Scholar
• National Institutes of Health. NIH state-of-the-science conference statement on manifestations and management of chronic insomnia in adults. NIH Consens Sci Statements 2005;22(2):1–30.
   Google Scholar
• Zeitzer JM, Ayas NT, Shea SA, Brown R, Czeisler CA. Absence of detectable melatonin and preservation of cortisol and thyrotropin rhythms in tetraplegia. J Clin Endocrinol Metab 2000;85(6):2189–96.
   PubMed Web of Science ®Google Scholar
• Dijk D-J, Cajochen C. Melatonin and the circadian regulation of sleep initiation, consolidation, structure, and the sleep EEG. J Biol Rhythms 1997;12(6):627–35.
   PubMed Web of Science ®Google Scholar
• Reiter RJ, Rudeen PK, Banks AF, Rollag MD. Acute effects of unilateral or bilateral superior cervical ganglionectomy on rat pineal N-acetyltransferase activity and melatonin content. Experientia 1979;35(5):691–2.
   PubMedGoogle Scholar
• von Gall C, Stehle JH, Weaver DR. Mammalian melatonin receptors: molecular biology and signal transduction. Cell Tissue Res 2002;309(1):151–62.
   PubMed Web of Science ®Google Scholar
• Dijk D-J, Czeisler CA. Contribution of the circadian pacemaker and the sleep homeostat to sleep propensity, sleep structure, electroencephalographic slow waves, and sleep spindle activity in humans. J Neurosci 1995;15(5):3526–38.
   PubMed Web of Science ®Google Scholar
• Dijk D-J, Czeisler CA. Paradoxical timing of the circadian rhythm of sleep propensity serves to consolidate sleep and wakefulness in humans. Neurosci Lett 1994;166(1):63–8.
   PubMed Web of Science ®Google Scholar
• Zeitzer JM, Daniels JE, Duffy JF, Klerman EB, Shanahan TL, Dijk D-J, et al. Plasma melatonin concentration: does it decline with age? Am J Med 1999;107(5):432–6.
   PubMed Web of Science ®Google Scholar
• Kräuchi K, Cajochen C, Werth E, Wirz-Justice A. Warm feet promote the rapid onset of sleep. Nature 1999;401(6748):36–7.
   PubMed Web of Science ®Google Scholar
• McGinty D, Gong H, Suntsova N, Alam MN, Methippara M, Guzman-Marin R, et al. Sleep-promoting functions of the hypothalamic median preoptic nucleus: inhibition of arousal systems. Arch Ital Biol 2004;142(4):501–9.
   PubMed Web of Science ®Google Scholar
• Fetsch CR, Heideman PD, Griffin JD. Effects of melatonin on thermally classified anterior hypothalamic neurons in the white-footed mouse (Peromyscus leucopus). J Thermal Biol 2006;31(1–2):40–9.
   Web of Science ®Google Scholar
• Viswanathan M, Laitinen JT, Saavedra JM. Expression of melatonin receptors in arteries involved in thermoregulation. Proc Natl Acad Sci USA 1990;87(16):6200–3.
   PubMed Web of Science ®Google Scholar
• Buscemi N, Vandermeer B, Hooton N, Pandya R, Tjosvold L, Hartling L, et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. Br Med J 2006;332(7538):385–93.
   PubMed Web of Science ®Google Scholar
• Williamson BL, Tomlinson AJ, Mishra PK, Gleich GJ, Naylor S. Structural characterization of contaminants found in commercial preparations of melatonin: similarities to case-related compounds from L-tryptophan associated with eosinophilia-myalgia syndrome. Chem Res Toxicol 1998;11(3):234–40.
   PubMed Web of Science ®Google Scholar
• Kirshblum SC, Burns SP, Biering-Sørensen F, Donovan W, Graves DE, Jha A, et al. International standards for neurological classification of spinal cord injury (Revised 2011). J Spinal Cord Med 2011;34(6):535–46.
   PubMed Web of Science ®Google Scholar
• Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG. AUDIT: the Alcohol Use Disorders Identification Test, guidelines for use in primary care. Geneva: World Health Organization: Department of Mental Health and Substance Dependence; 2001.
   Google Scholar
• Zeitzer JM, Dijk D-J, Kronauer RE, Brown EN, Czeisler CA. Sensitivity of the human circadian pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol 2000;526(Pt3):695–702.
   PubMed Web of Science ®Google Scholar
• Mahlberg R, Tilmann A, Salewski L, Kunz D. Normative data on the daily profile of urinary 6-sulfatoxymelatonin in healthy subjects between the ages of 20 and 84. Psychoneuroendocrinol 2006;31(5):634–41.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Horne JA, Östberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Intl J Chronobiol 1976;4(2):97–110.
   PubMedGoogle Scholar
• Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961;4(Jun):561–71.
   PubMed Web of Science ®Google Scholar
• Spielberger C, Gorusch RI, Lushene R, Vagg PR, Jacobs GA. State-trait anxiety inventory for adults. Palo Alto, CA: Consulting Psychologists Press Inc.; 1983.
   Google Scholar
• Landrum RE. College students' use of caffeine and its relationship to personality. College Student J 1992;126(2):151–5.
   Google Scholar
• Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin brief pain questionnaire to assess pain in cancer and other diseases. Pain 1983;17(2):197–210.
   PubMed Web of Science ®Google Scholar
• Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollack CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep 2003;26(3):342–92.
   PubMed Web of Science ®Google Scholar
• Zeitzer JM. Physiology and anatomy of human circadian photoreception and melatonin regulation [doctoral thesis]. Cambridge, MA: Harvard University; 1999.
   Google Scholar
• Spivak E, Oksenberg A, Catz A. The feasibilty of sleep assessment by actigraph in patients with tetraplegia. Spinal Cord 2007;45(12):765–70.
   PubMed Web of Science ®Google Scholar
• Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC. Quantification of sleepiness: a new approach. Psychophysiol 1973;10(4):431–6.
   PubMed Web of Science ®Google Scholar
• Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30(6):473–83.
   PubMed Web of Science ®Google Scholar
• Forchheimer M, McAweeney M, Tate DG. Use of the SF-36 among persons with spinal cord injury. Am J Phys Med Rehabil 2004;83(5):390–5.
   PubMed Web of Science ®Google Scholar
• Cassone VM, Roberts MH, Moore RY. Melatonin inhibits metabolic activity in the rat suprachiasmatic nucleus. Neurosci Lett 1987;81(1–2):29–34.
   PubMed Web of Science ®Google Scholar
• Shibata S, Cassone VM, Moore RY. Effects of melatonin on neuronal activity in the rat suprachiasmatic nucleus in vitro. Neurosci Lett 1989;97(1–2):140–4.
   PubMed Web of Science ®Google Scholar
• Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285(15):1987–91.
   PubMed Web of Science ®Google Scholar