Sleep Clinical Trial
Official title:
Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night
The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.
Status | Completed |
Enrollment | 26 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 18 to 50 years of age - no sleep complaints or problems - good sleep quality per questionnaire - sufficient time in bed each night Exclusion Criteria: - any clinically significant unstable medical condition - recent psychiatric disorder - prior diagnosis or symptoms of a sleep disorder - recent history of substance abuse - recent use of prescription hypnotic medication or over-the-counter sleep aid - recent use of psychotropic medication - history of adverse reaction to benzodiazepines - body mass index > 36 - currently pregnant or nursing - currently working rotating or night shift - consumption of > 700 mg per day of xanthine-containing food or beverages - consumption of > 14 units of alcohol per week - smoke > 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | St. Luke's Hospital Sleep Medicine and Research Center | Chesterfield | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Luke's Hospital, Chesterfield, Missouri | American Academy of Sleep Medicine |
United States,
Greenblatt DJ, Harmatz JS, von Moltke LL, Ehrenberg BL, Harrel L, Corbett K, Counihan M, Graf JA, Darwish M, Mertzanis P, Martin PT, Cevallos WH, Shader RI. Comparative kinetics and dynamics of zaleplon, zolpidem, and placebo. Clin Pharmacol Ther. 1998 Nov;64(5):553-61. — View Citation
Weinling E, McDougall S, Andre F, Bianchetti G, Dubruc C. Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. Fundam Clin Pharmacol. 2006 Aug;20(4):397-403. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Memory | Two memory tasks will be used to assess memory. | 8 timepoints: 4 evenings and 4 mornings | No |
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