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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209728
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Insomnia Other: Placebo/ethanol (blinded) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
Study Start Date : October 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Primary insomnia patients and healthy subjects
Elderly participants, including primary insomnia patients and healthy subjects
Other: Placebo/ethanol (blinded)
Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner
Other Name: Placebo or ethanol (blinded)

Primary Outcome Measures :
  1. Simulated driving variables [ Time Frame: 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).

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01209728     History of Changes
Other Study ID Numbers: 0000-183
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Merck Sharp & Dohme Corp.:
simulated driving

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs