Effects of Insomnia on Simulated Driving (MK-0000-183-00)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
|Official Title:||A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs|
- 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).
|Study Start Date:||October 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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)