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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01209728
First received: September 24, 2010
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Insomnia
Other: Placebo/ethanol (blinded)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Simulated driving variables [ Time Frame: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day. ] [ Designated as safety issue: No ]
    Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).


Enrollment: 76
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01209728     History of Changes
Other Study ID Numbers: 0000-183
Study First Received: September 24, 2010
Last Updated: September 18, 2013
Health Authority: United States: Schulman IRB

Keywords provided by Merck Sharp & Dohme Corp.:
insomnia
insomniacs
simulated driving
alcohol
ethanol

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014