Status:
COMPLETED
Effects of Insomnia on Simulated Driving (MK-0000-183-00)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Insomnia
Eligibility:
All Genders
65+ years
Phase:
PHASE1
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 defic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01209728
Start Date
October 1 2010
End Date
September 1 2011
Last Update
June 12 2019
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