Trial Outcomes & Findings for Memory Consolidation in Pharmacologically Enhanced Naps (NCT NCT00777829)

NCT ID: NCT00777829

Last Updated: 2021-07-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Two weeks
• Results posted on: 2021-07-28

Participant Flow

Participant milestones

Measure	Zolpidem First, Then Placebo 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.	Placebo First, Then Zolpidem 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.
Overall Study STARTED	15	15
Overall Study Study Orientation	15	13
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Zolpidem First, Then Placebo 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.	Placebo First, Then Zolpidem 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.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Memory Consolidation in Pharmacologically Enhanced Naps

Baseline characteristics by cohort

Measure	All Participants n=30 Participants This was a within-subjects design, so all 30 started in the participant flow, but only 28 completed all arms of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

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

Outcome measures

Measure	Zolpidem n=28 Participants This arm reflects all participants who received the drug (one dose of 10mg before each nap) during the entire course of the study.	Placebo n=28 Participants This arm reflects all participants who received the placebo (a dose of placebo before each nap) during the entire course of the study.
Pharmacological Enhancement of Specific Sleep Parameters	3 sleep spindles Standard Deviation 0.5	1 sleep spindles Standard Deviation 0.5

SECONDARY outcome

Timeframe: two weeks

improvement on a verbal memory task in active drug. We measured the number of words recalled.

Outcome measures

Measure	Zolpidem n=28 Participants This arm reflects all participants who received the drug (one dose of 10mg before each nap) during the entire course of the study.	Placebo n=28 Participants This arm reflects all participants who received the placebo (a dose of placebo before each nap) during the entire course of the study.
Correlation of Pharmacological Interventions With Sleep-stage-specific Memory Tasks	3 recall of words Standard Deviation 1.0	1 recall of words Standard Deviation 0.5

Adverse Events

Zolpidem

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Zolpidem n=28 participants at risk This arm reflects all participants who received the drug (1 dose of 10mg before each nap) during the entire course of the study.	Placebo n=28 participants at risk This arm reflects all participants who received the placebo (1 dose of placebo before each nap) during the entire course of the study.
General disorders drowsiness	60.7% 17/28	0.00% 0/28
General disorders dizziness	42.9% 12/28	0.00% 0/28
General disorders nausea	14.3% 4/28	0.00% 0/28
General disorders vomiting	7.1% 2/28	0.00% 0/28

Additional Information

Dr. Sara C. Mednick

UCSD

Phone: 8586423192

Email: mednicks@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place