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Hypnotic Medications and Memory: Effect of Drug Exposure During the Night

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ClinicalTrials.gov Identifier: NCT01159652
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : August 26, 2014
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by (Responsible Party):
St. Luke's Hospital, Chesterfield, Missouri

Tracking Information
First Submitted Date  ICMJE July 8, 2010
First Posted Date  ICMJE July 9, 2010
Last Update Posted Date August 26, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
Memory [ Time Frame: 8 timepoints: 4 evenings and 4 mornings ]
Two memory tasks will be used to assess memory.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01159652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypnotic Medications and Memory: Effect of Drug Exposure During the Night
Official Title  ICMJE Hypnotic Medications and Sleep-dependent Memory Consolidation: the Effect of Variable Drug Exposure During the Night
Brief Summary 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.
Detailed Description

A growing body of evidence has demonstrated that sleep promotes memory consolidation in healthy individuals. However, little research has been conducted regarding the effect of hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers. Another study reported significant impairment of sleep-dependent memory on a motor task with triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation, but further investigation is clearly needed in this area. Because hypnotics are commonly prescribed for insomnia, it is important to determine if there is a significant risk of impairment in sleep-dependent memory consolidation associated with these medications. Further, investigation of alternative doses and drug regimens upon memory consolidation appears warranted.

The purpose of the current study is to determine the effect of two hypnotic medications on sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which will be active for most of the sleep period when administered at bedtime, will be compared to zaleplon, which will be active for half of the sleep period when administered in the middle of the night. This comparison allows us to address the question of whether a few hours of drug-free sleep results in better memory consolidation than sleep with drug throughout the night.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE
  • Sleep
  • Memory
Intervention  ICMJE
  • Drug: zaleplon
    10 mg
    Other Name: Sonata
  • Drug: zolpidem extended release
    12.5 mg
    Other Name: Ambien CR
  • Drug: bedtime placebo
    placebo
  • Drug: middle of the night placebo
    placebo
Study Arms  ICMJE
  • Placebo Comparator: Bedtime Placebo
    Intervention: Drug: bedtime placebo
  • Placebo Comparator: Middle of the Night Placebo
    Intervention: Drug: middle of the night placebo
  • Experimental: Zolpidem
    Intervention: Drug: zolpidem extended release
  • Experimental: Zaleplon
    Intervention: Drug: zaleplon
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2010)
20
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159652
Other Study ID Numbers  ICMJE 63-SR-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's Hospital, Chesterfield, Missouri
Study Sponsor  ICMJE St. Luke's Hospital, Chesterfield, Missouri
Collaborators  ICMJE American Academy of Sleep Medicine
Investigators  ICMJE
Principal Investigator: Janine M Hall-Porter, PhD St. Luke's Hospital
PRS Account St. Luke's Hospital, Chesterfield, Missouri
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP