Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

Summary

Insomnia is a widespread condition in which approximately one-third of adults in the United States are symptomatic with 6% of the population meeting the diagnostic criteria for insomnia. There is an increased risk of insomnia in certain segments of the population including women, middle-aged and older adults, shift workers and individuals with medical or psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to those who report other serious illnesses such as major depression and congestive heart failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric disorders, medical and neurologic disorders. It can impair cognitive and physical functioning. Propofol is an approved drug administered intravenously for use in the induction and maintenance of anesthesia or sedation. Some research suggests that propofol when administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening and the integrity of behavior following waking. This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct care of a Board Certified Anesthesiologist, dedicated to the study involving participants who have refractory chronic primary insomnia and have not responded to conventional pharmacologic therapies within the past 90 days. Each qualifying participant will receive an IV infusion of the study medication for 5 consecutive nights. Assessments including polysomnography with completion of questionnaires will occur at screening, Days 1 through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day 180.

Timeline

Start

2013-06

Primary completion

2015-05

Completion

2015-05

Publications

• Background American College of Chest Physicians. Diagnosis and Treatment of Insomnia. http://chestnet.org/accp/pccsu/diagnosis-and-treatment-insomnia?page=0.3. Published September 3, 2007. Accessed February 6, 2012.
• Background Barr J, Egan TD, Sandoval NF, Zomorodi K, Cohane C, Gambus PL, Shafer SL. Propofol dosing regimens for ICU sedation based upon an integrated pharmacokinetic-pharmacodynamic model. Anesthesiology. 2001 Aug;95(2):324-33. doi: 10.1097/00000542-200108000-00011.
• Background http://www.drugs.com/pro/propofol
• Background http://www.drugs.com/mmx/propofol.html)
• Background Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002 Mar;51(3):229-35.
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• Background Murphy M, Bruno MA, Riedner BA, Boveroux P, Noirhomme Q, Landsness EC, Brichant JF, Phillips C, Massimini M, Laureys S, Tononi G, Boly M. Propofol anesthesia and sleep: a high-density EEG study. Sleep. 2011 Mar 1;34(3):283-91A. doi: 10.1093/sleep/34.3.283.
• Background Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
• Background Rabelo FA, Braga A, Kupper DS, De Oliveira JA, Lopes FM, de Lima Mattos PL, Barreto SG, Sander HH, Fernandes RM, Valera FC. Propofol-induced sleep: polysomnographic evaluation of patients with obstructive sleep apnea and controls. Otolaryngol Head Neck Surg. 2010 Feb;142(2):218-24. doi: 10.1016/j.otohns.2009.11.002.
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• Background Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
• Background Saddichha S. Diagnosis and treatment of chronic insomnia. Ann Indian Acad Neurol. 2010 Apr;13(2):94-102. doi: 10.4103/0972-2327.64628.
• Background Tung A, Bergmann BM, Herrera S, Cao D, Mendelson WB. Recovery from sleep deprivation occurs during propofol anesthesia. Anesthesiology. 2004 Jun;100(6):1419-26. doi: 10.1097/00000542-200406000-00014.
• Background Tung A, Lynch JP, Mendelson WB. Prolonged sedation with propofol in the rat does not result in sleep deprivation. Anesth Analg. 2001 May;92(5):1232-6. doi: 10.1097/00000539-200105000-00028.
• Background Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol. 2008;(182):227-52. doi: 10.1007/978-3-540-74806-9_11.
• Background Xu Z, Jiang X, Li W, Gao D, Li X, Liu J. Propofol-induced sleep: efficacy and safety in patients with refractory chronic primary insomnia. Cell Biochem Biophys. 2011 Jul;60(3):161-6. doi: 10.1007/s12013-010-9135-7.

Drugs

Indications