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Clinical Trials/NCT01209728
NCT01209728
Completed
Phase 1

A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs

Merck Sharp & Dohme LLC0 sites76 target enrollmentOctober 1, 2010
ConditionsInsomnia

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2010
End Date
September 1, 2011
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

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