Number of sleep spindles comparing placebo vs active drug. We count spindles in the EEG record.
Memory Consolidation in Pharmacologically Enhanced Naps
zolpidem (DRUG)Participants will receive one dose of 10 mg before each nap.
Placebo (DRUG)Participants will receive a dose of placebo before each nap.
Condition or Disease
|No Results Available
|18 Years to 39 Years
|Health Services Research
Clinical Trial Dates
|Sep 01, 2008
|Jun 01, 2011
|Jun 01, 2011
|Study First Posted:
|Oct 22, 2008
|Results First Posted:
|Jul 28, 2021
|Jul 07, 2021
Sponsors / Collaborators
New drugs can target specific sleep stages and increase the amount of time people spend in those stages when they sleep. For example, the new prescription drug zolpidem increases time spent in stage 2 during sleep, and the drug sodium oxybate increases time spent in SWS. Compared to sleep impacted by either zolpidem or sodium oxybate, normal sleep has proportionally more time spent in REM. This study will use medications, or their lack, to manipulate how much time is spent in REM, stage 2, and SWS. The study will then examine whether the percentage of sleep spent in different stages affects the learning processes associated with those stages.
Participation in this study will last 6 weeks. At the outset, participants will undergo a 2-hour screening visit that will include a medical history, a physical examination, routine lab tests, urine tests for drugs and pregnancy, an electrocardiogram, and a clinical interview for mental health. Participants will also be asked to complete a series of questionnaires on subjective sleep quality, sleep quantity, and daytime sleepiness.
Participants will complete five study visits, beginning 1 week from screening and separated by 5 to 10 days to allow drug wash-out and recovery from effects of the previous visit. Each study visit will involve an overnight stay in a sleep lab. Participants will arrive at 8 PM, go to bed at 10 PM, and be awakened at 5 AM. Between 6 and 8 AM, they will undergo three different tests, each corresponding to a different type of learning and memory process: perceptual, motor, or declarative. The test will include recognizing a target image, typing a specific finger sequence on a keyboard, and verbally recalling a list of words. Participants will receive one of the study drugs or placebo at 8:30 AM and then be allowed to take a 90-minute nap between 9 and 11 AM. They will receive a different drug, different dosage, or placebo at each study visit. Between 4 and 6 PM, they will be retested on the previous three tests. While sleeping, participants will be outfitted with sensors monitoring muscle activity, eye movements, brain waves, heart and lung functioning, and-on the first night-breathing.
For the entire duration of the study, participants will wear an actigraph, which is a wristwatch-like device that monitors sleep cycles. Participants will also be required to maintain a regular sleep schedule, going to sleep and waking up in the same 2-hour window each day. They will also report on sleep schedule and caffeine, alcohol, and drug use in a daily sleep diary. Caffeine, alcohol, and drug use will be prohibited starting at noon on the day prior to each study visit.
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.
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.
* 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
* 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
improvement on a verbal memory task in active drug. We measured the number of words recalled.