effects of insomnia on simulated driving (mk-0000-183-00)

Conditions: Insomnia

Summary: this is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. the objectives if this study are primarily: 1. to determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. to compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (sdlp), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.


Eligibility criteria:
inclusion criteria a patient or subject may participate in the study if, at least, the all of the criteria below are met. the participant: * is a male or female of non-childbearing potential and 65 years of age or older at prestudy (screening); * has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months prior to screening; * has a current valid driver's license; * their regular bedtime is between 9 pm (21:00) and 12 am (00:00); * during the study, are willing to refrain from napping; additionally, a primary insomnia patient must meet the following inclusion criteria: * has a diagnosis of primary insomnia; * reports total sleep time of \< 6 hours on at least 3 out of 7 nights each week during the 4 weeks prior to screening; * reports spending 6 to 9 hours nightly in bed on at least 3 out of 7 nights each week during the 4 weeks prior to screening. exclusion criteria : a patient may not participate in the study if any of the criteria below (among others determined by the study staff) apply. the participant: * has visual or auditory impairment; * has a history of clinically significant endocrine (including diabetes), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; * has a history of neoplastic disease ; * is taking, or plans to take, one or more of the following medications (non-inclusive), within the 2 weeks prior to screening and throughout the course of the study: centrally acting anticholinergics or antihistamines; melatonin; anticonvulsants; antipsychotics; anxiolytics; benzodiazepines; hypnotics; any cns depressants; over-the-counter medications that could affect sleep; stimulants; diet pills; anti-depressants; disulfiram; * has a positive screening urine drug test (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.); * has a lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder or a psychiatric condition requiring treatment with a prohibited medication; or other current psychiatric condition that, in the investigator's opinion, would interfere with the subject/patient's ability to participate in the study ; * has evidence of suicidality; * has a history of transmeridian travel (across \> 3 time zones or \> 3 hour time difference) within two weeks prior to screening or anticipates transmeridian travel during the study; * has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past two weeks prior to screening or anticipates need to perform shift work during the study; * has a history or diagnosis of any of following conditions, in the opinion of the investigator: narcolepsy; cataplexy (familial or idiopathic); circadian rhythm sleep disorder; parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rem behavior disorder; sleep-related breathing disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome); periodic limb movement disorder; restless legs syndrome; primary hypersomia; excessive daytime sleepiness (eds), not attributable to primary insomnia * has a recent and/or active history of a confounding neurological disorder, including but not limited to: seizure disorder, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness and residual impairment within the last 10 years; * has a history of allergy, exceptional sensitivity, or adverse reaction to alcohol; * has a significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening; * consumes excessive amounts of alcohol or subject or patient consumes alcohol to promote sleep (i.e., within 3 hours before going to bed); * has never consumed alcohol; * consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages.

Keywords: insomnia insomniacs simulated driving alcohol ethanol