A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 76
- Primary Endpoint
- Simulated driving variables
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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).