Effects of Insomnia on Simulated Driving (MK-0000-183-00)
- Conditions
- Insomnia
- Interventions
- Other: Placebo/ethanol (blinded)
- Registration Number
- NCT01209728
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary insomnia patients and healthy subjects Placebo/ethanol (blinded) Elderly participants, including primary insomnia patients and healthy subjects
- Primary Outcome Measures
Name Time Method Simulated driving variables 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).
- Secondary Outcome Measures
Name Time Method