Memory Consolidation in Pharmacologically Enhanced Naps

NCT00777829 | Completed Results DMC

• 3 other identifiers: K01MH080992-01071529DNBBS 7K-TGNB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether various drugs affecting sleep cycles can improve different kinds of memory.

Conditions

Sleep

Keywords

Nap; Pharmacology; Memory; Visual Learning; Verbal Memory; Motor Learning

Outcome Measures

Primary Outcomes (1)

• Pharmacological Enhancement of Specific Sleep Parameters

  Number of sleep spindles comparing placebo vs active drug. We count spindles in the EEG record.

  Two weeks

Secondary Outcomes (1)

• Correlation of Pharmacological Interventions With Sleep-stage-specific Memory Tasks

  two weeks

Study Arms (2)

zolpidem first, then placebo

EXPERIMENTAL

Participants received one dose of zolpidem for one nap, then had a one week washout period, followed by once dose of placebo for one nap.

Drug: zolpidem; Drug: Placebo

Placebo first, then zolpidem

PLACEBO COMPARATOR

Participants received one dose of placebo for one nap, then had a one week washout period, followed by once dose of zolpidem for one nap.

Drug: zolpidem; Drug: Placebo

Interventions

zolpidem DRUG

Participants will receive one dose of 10 mg before each nap.

Placebo first, then zolpidem; zolpidem first, then placebo

Placebo DRUG

Participants will receive a dose of placebo before each nap.

Placebo first, then zolpidem; zolpidem first, then placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speaks English
• Resides in the general San Diego community
• Completed at least 12 years of formal education, because education may affect performance on the cognitive task

You may not qualify if:

• No regular sleep-wake schedule, defined as not meeting study criteria or scoring between 31 and 69 on the Horne-Ostberg Morningness-Eveningness Questionnaire
• Presence of a sleep disorder reported or detected on the questionnaires
• Personal or immediate family (i.e., first degree relative) history of diagnosed significant psychopathology
• Personal history of head injury with loss of consciousness for more than 15 minutes or with seizures
• History of substance dependence
• Current use of any psychotropic medications
• Any cardiac, respiratory, or other medical condition that may affect cerebral metabolism
• Noncorrectable vision and audition impairments

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSD General Clinical Research Center Laboratory for Sleep and Chronobiology (GCRC-LSC)

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Spatial Learning

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Sara C. Mednick
• Organization: UCSD

mednicks@uci.edu

8586423192

Study Officials

• Sara C. Mednick, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Locations

US (1)