Bastien CH, Vallières A, Morin CM Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307.
Benca RM Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005 Mar;56(3):332-43. Review.
Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
Curtis BJ, Williams PG, Jones CR, Anderson JS Sleep duration and resting fMRI functional connectivity: examination of short sleepers with and without perceived daytime dysfunction. Brain Behav. 2016 Sep 15;6(12):e00576. doi: 10.1002/brb3.576. eCollection
Dodds KL, Miller CB, Kyle SD, Marshall NS, Gordon CJ Heart rate variability in insomnia patients: A critical review of the literature. Sleep Med Rev. 2017 Jun;33:88-100. doi: 10.1016/j.smrv.2016.06.004. Epub 2016 Jun 28. Review.
Equihua-Benítez AC, Guzmán-Vásquez K, Drucker-Colín R Understanding sleep-wake mechanisms and drug discovery. Expert Opin Drug Discov. 2017 Jul;12(7):643-657. doi: 10.1080/17460441.2017.1329818. Epub 2017 May 22. Review.
Grønli J, Soulé J, Bramham CR Sleep and protein synthesis-dependent synaptic plasticity: impacts of sleep loss and stress. Front Behav Neurosci. 2014 Jan 21;7:224. doi: 10.3389/fnbeh.2013.00224. eCollection 2013. Review.
Halász P, Bódizs R, Parrino L, Terzano M Two features of sleep slow waves: homeostatic and reactive aspects--from long term to instant sleep homeostasis. Sleep Med. 2014 Oct;15(10):1184-95. doi: 10.1016/j.sleep.2014.06.006. Epub 2014 Jul 8. Review.
Jäkel A, von Hauenschild P Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93. Review.
Levendowski DJ, Popovic D, Berka C, Westbrook PR Retrospective cross-validation of automated sleep staging using electroocular recording in patients with and without sleep disordered breathing. Int Arch Med. 2012 Jun 25;5(1):21. doi: 10.1186/1755-7682-5-
McCall WV Cognitive behavioral therapy for insomnia (CBT-I): What is known, and advancing the science by avoiding the pitfalls of the placebo effect. Sleep Med Rev. 2018 Apr;38:1-2. doi: 10.1016/j.smrv.2017.05.001. Epub 2017 May 5.
Medrano-Martínez P, Ramos-Platón MJ [Cognitive and emotional alterations in chronic insomnia]. Rev Neurol. 2016 Feb 16;62(4):170-8. Review. Spanish.
Morin CM, Belleville G, Bélanger L, Ivers H The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8.
Morin CM, Benca R Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20. Review. Erratum in: Lancet. 2012 Apr 21;379(9825):1488.
Ohayon MM, Sagales T Prevalence of insomnia and sleep characteristics in the general population of Spain. Sleep Med. 2010 Dec;11(10):1010-8. doi: 10.1016/j.sleep.2010.02.018. Epub 2010 Nov 18.
Ohayon MM Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111.
Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Feb 15;13(2):307-349. doi: 10.5664/jcsm.6470.
Sateia MJ International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970. Review.
Schmid A, Brunner F, Wright A, Bachmann LM Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
Short NA, Allan NP, Raines AM, Schmidt NB The effects of an anxiety sensitivity intervention on insomnia symptoms. Sleep Med. 2015 Jan;16(1):152-9. doi: 10.1016/j.sleep.2014.11.004. Epub 2014 Nov 25.
Veqar Z, Hussain ME Validity and reliability of insomnia severity index and its correlation with pittsburgh sleep quality index in poor sleepers among Indian university students. Int J Adolesc Med Health. 2017 Jan 7;32(1). pii: /j/ijamh.2020.32.issue-1/ijamh-2016-0090/ijamh-2016-0090.xml. doi: 10.1515/ijamh-2016-0090.
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.