Effects of Insomnia on Simulated Driving (MK-0000-183-00)

Study Overview
=================
Brief 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.

Official Title
-----------------
A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Other: Placebo/ethanol (blinded)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary insomnia patients and healthy subjects<br>Elderly participants, including primary insomnia patients and healthy subjects | Other: Placebo/ethanol (blinded)<br>* Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner<br>* Other names: Placebo or ethanol (blinded);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulated driving variables | Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables). | Evaluated on, up to, 3 different days, with 2 driving sessions of  65 minutes each day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insomnia, insomniacs, simulated driving, alcohol, ethanol