Insomnia
Conditions
Keywords
insomnia, insomniacs, simulated driving, alcohol, ethanol
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.
Interventions
OTHERPlacebo/ethanol (blinded)
Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simulated driving variables | Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day. | Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables). |
Outcome results
None listed