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

NCT01209728 | Completed Phase 1

• 1 other identifier: 0000-183
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

insomnia; insomniacs; simulated driving; alcohol; ethanol

Outcome Measures

Primary Outcomes (1)

• Simulated driving variables

  Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).

  Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.

Study Arms (1)

Primary insomnia patients and healthy subjects

EXPERIMENTAL

Elderly participants, including primary insomnia patients and healthy subjects

Other: Placebo/ethanol (blinded)

Interventions

Placebo/ethanol (blinded) OTHER

Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner

Also known as: Placebo or ethanol (blinded)

Primary insomnia patients and healthy subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 26240742 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share