Trial Outcomes & Findings for Sleep and Emotional Memory in Peripubertal Anxiety (NCT NCT03643848)
NCT ID: NCT03643848
Last Updated: 2025-09-11
Results Overview
Emotional Mnemonic Similarity Task. Participants view pictures depicting negative or neutral objects/scenes. After a delay period (1 week) they are presented with a second set of pictures that are the same (targets), slightly different (lures), or completely different (foils) from the first series of pictures. They are told to indicate by button press if images they are currently viewing are "old" or "new". Responding to the lures as old ("false alarms") provides a signature of generalization for each participant. To correct for response biases (i.e., a tendency to label items as "old") a Lure Generalization Index (LGI) is calculated which reflects corrected memory generalization by subtracting false alarm rates to foils from false alarm rates to lures. Larger LGI values indicate greater generalization (i.e., greater tendency to misidentify similar items as previously seen, accounting for overall biases to identify any items as previously seen). Minimum value -1 and maximum value =1
COMPLETED
NA
58 participants
Delayed recall, 1 week
2025-09-11
Participant Flow
recruitment from community and outpatient mental health clinics for children
Participant milestones
| Measure |
Sleep With Sound Cues
Sounds played at time of memory encoding will be replayed during sleep to cue memory processing.
Sleep with Sound Cues: Experimental manipulation to observe effects on memory for learned material.
|
Sleep With Sham Cues
Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison
Sleep with Sham Cues: Sham manipulation
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep and Emotional Memory in Peripubertal Anxiety
Baseline characteristics by cohort
| Measure |
Sleep With Sound Cues
n=29 Participants
Sounds played at time of memory encoding will be replayed during sleep to cue memory processing.
Sleep with Sound Cues: Experimental manipulation to observe effects on memory for learned material.
|
Sleep With Sham Cues
n=29 Participants
Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison
Sleep with Sham Cues: Sham manipulation
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
11.4 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Anxiety Severity Composite
|
1.4 units on a scale (standardized factor)
STANDARD_DEVIATION 1.0 • n=5 Participants
|
1.3 units on a scale (standardized factor)
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.4 units on a scale (standardized factor)
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Delayed recall, 1 weekEmotional Mnemonic Similarity Task. Participants view pictures depicting negative or neutral objects/scenes. After a delay period (1 week) they are presented with a second set of pictures that are the same (targets), slightly different (lures), or completely different (foils) from the first series of pictures. They are told to indicate by button press if images they are currently viewing are "old" or "new". Responding to the lures as old ("false alarms") provides a signature of generalization for each participant. To correct for response biases (i.e., a tendency to label items as "old") a Lure Generalization Index (LGI) is calculated which reflects corrected memory generalization by subtracting false alarm rates to foils from false alarm rates to lures. Larger LGI values indicate greater generalization (i.e., greater tendency to misidentify similar items as previously seen, accounting for overall biases to identify any items as previously seen). Minimum value -1 and maximum value =1
Outcome measures
| Measure |
Sleep With Sound Cues (Targeted Memory Reactivation [TMR])
n=28 Participants
Sounds played at time of memory encoding for neutral stimuli will be replayed during sleep to cue neutral memory processing (and displace negative memory processing).
Sleep with Sound Cues: Experimental manipulation to observe effects on memory for learned material.
|
Sleep With Sham Cues (Sham)
n=28 Participants
Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison
Sleep with Sham Cues: Sham manipulation
|
|---|---|---|
|
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
Lure Generalization Index for Negatively Valenced Stimuli
|
.24 units on a scale
Standard Deviation .16
|
.26 units on a scale
Standard Deviation .12
|
|
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
Lure Generalization Index for Neutral Stimuli
|
.14 units on a scale
Standard Deviation .15
|
.10 units on a scale
Standard Deviation .11
|
SECONDARY outcome
Timeframe: Recall, 12 hoursEmotional Mnemonic Similarity Task. Participants view pictures depicting negative or neutral objects/scenes. After a delay period (12 hours) they are presented with a second set of pictures that are the same (targets), slightly different (lures), or completely different (foils) from the first series of pictures. They are told to indicate by button press if images they are currently viewing are "old" or "new". Responding to the lures as old ("false alarms") provides a signature of generalization for each participant. To correct for response biases (i.e., a tendency to label items as "old") a Lure Generalization Index (LGI) is calculated which reflects corrected memory generalization by subtracting false alarm rates to foils from false alarm rates to lures. Larger LGI values indicate greater generalization (i.e., greater tendency to misidentify similar items as previously seen, accounting for overall biases to identify any items as previously seen). Minimum value -1 and maximum value =1
Outcome measures
| Measure |
Sleep With Sound Cues (Targeted Memory Reactivation [TMR])
n=29 Participants
Sounds played at time of memory encoding for neutral stimuli will be replayed during sleep to cue neutral memory processing (and displace negative memory processing).
Sleep with Sound Cues: Experimental manipulation to observe effects on memory for learned material.
|
Sleep With Sham Cues (Sham)
n=29 Participants
Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison
Sleep with Sham Cues: Sham manipulation
|
|---|---|---|
|
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
Lure Generalization Index for Negatively Valenced Stimuli
|
.40 units on a scale
Standard Deviation .19
|
.40 units on a scale
Standard Deviation .21
|
|
Scores on the Lure Generalization Index (a Behavioral Measure of Generalization)
Lure Generalization Index for Neutral Stimuli
|
.26 units on a scale
Standard Deviation .19
|
.30 units on a scale
Standard Deviation .16
|
Adverse Events
Sleep With Sound Cues
Sleep With Sham Cues
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dana L. McMakin, PhD, ABPP
Florida International University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place