Clinical trial NCT01209728: Effects of Insomnia on Simulated Driving (MK-0000-183-00)
Official title: A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Keywords: insomnia
insomniacs
simulated driving
alcohol
ethanol
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 76
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Simulated driving variables
timeFrame: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Simen AA, Gargano C, Cha JH, Drexel M, Bautmans A, Heirman I, Laethem T, Hochadel T, Gheyle L, Bleys K, Beals C, Stoch A, Kay GG, Struyk A. A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. Ther Adv Drug Saf. 2015 Jun;6(3):86-97. doi: 10.1177/2042098615579314.