Trial Outcomes & Findings for Narcolepsy Nightmare Study (NCT NCT05709873)
NCT ID: NCT05709873
Last Updated: 2026-06-30
Results Overview
Frequency of nightmares as measured by daily diary
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Imagery Rehearsal Therapy (IRT)
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Imagery Rehearsal Therapy (IRT)
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Only data for completed participants were analyzed for the manuscript.
Baseline characteristics by cohort
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
0 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
0 Participants
n=40 Participants • Only data for completed participants were analyzed for the manuscript.
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
3 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
6 Participants
n=40 Participants • Only data for completed participants were analyzed for the manuscript.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
0 Participants
n=20 Participants • Only data for completed participants were analyzed for the manuscript.
|
0 Participants
n=40 Participants • Only data for completed participants were analyzed for the manuscript.
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of nightmares as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Nightmare Frequency
Baseline
|
12.75 nightmares per week
Standard Deviation 8.13
|
4.00 nightmares per week
Standard Deviation 1.39
|
|
Nightmare Frequency
Posttreatment
|
2.00 nightmares per week
Standard Deviation 1.00
|
2.50 nightmares per week
Standard Deviation 2.60
|
PRIMARY outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Disturbing Dream and Nightmare Severity Scale
Baseline
|
23.67 score on a scale
Standard Deviation 8.02
|
18.33 score on a scale
Standard Deviation 2.89
|
|
Disturbing Dream and Nightmare Severity Scale
Posttreatment
|
12.33 score on a scale
Standard Deviation 4.16
|
5.33 score on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Baseline
|
58.80 score on a scale
Standard Deviation 10.91
|
50.33 score on a scale
Standard Deviation 8.03
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Posttreatment
|
56.53 score on a scale
Standard Deviation 9.42
|
48.70 score on a scale
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Baseline
|
56.33 score on a scale
Standard Deviation 3.69
|
50.27 score on a scale
Standard Deviation 5.28
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Posttreatment
|
55.07 score on a scale
Standard Deviation 4.47
|
47.37 score on a scale
Standard Deviation 9.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of dream enactment as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Dream Enactment Frequency
Baseline
|
2.17 dream enactment episodes per week
Standard Deviation 2.57
|
1.42 dream enactment episodes per week
Standard Deviation 1.28
|
|
Dream Enactment Frequency
Posttreatment
|
1.00 dream enactment episodes per week
Standard Deviation 1.73
|
1.17 dream enactment episodes per week
Standard Deviation 1.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of sleep talking as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Sleep Talking Frequency
Baseline
|
12.92 sleep talking episodes per week
Standard Deviation 9.64
|
1.08 sleep talking episodes per week
Standard Deviation 1.66
|
|
Sleep Talking Frequency
Posttreatment
|
0.17 sleep talking episodes per week
Standard Deviation 0.29
|
0.83 sleep talking episodes per week
Standard Deviation 1.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of lucid dreams without control as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Lucid Dreams Without Control Frequency
Baseline
|
3.83 episodes per week
Standard Deviation 3.51
|
3.08 episodes per week
Standard Deviation 3.84
|
|
Lucid Dreams Without Control Frequency
Posttreatment
|
1.83 episodes per week
Standard Deviation 1.44
|
3.67 episodes per week
Standard Deviation 5.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of lucid dreams with control as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Lucid Dreams With Control Frequency
Baseline
|
2.42 episodes per week
Standard Deviation 3.97
|
2.83 episodes per week
Standard Deviation 4.91
|
|
Lucid Dreams With Control Frequency
Posttreatment
|
3.50 episodes per week
Standard Deviation 6.06
|
5.67 episodes per week
Standard Deviation 9.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of sleep-related hallucinations as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Sleep-related Hallucinations Frequency
Posttreatment
|
1.00 sleep-related hallucinations per week
Standard Deviation 1.00
|
1.17 sleep-related hallucinations per week
Standard Deviation 2.02
|
|
Sleep-related Hallucinations Frequency
Baseline
|
7.58 sleep-related hallucinations per week
Standard Deviation 8.32
|
1.50 sleep-related hallucinations per week
Standard Deviation 2.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)Population: Completed participants were included in analysis.
Frequency of sleep paralysis as measured by daily diary
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Sleep Paralysis Frequency
Posttreatment
|
0.83 sleep paralysis episodes per week
Standard Deviation 1.44
|
0.50 sleep paralysis episodes per week
Standard Deviation 0.00
|
|
Sleep Paralysis Frequency
Baseline
|
2.00 sleep paralysis episodes per week
Standard Deviation 1.80
|
1.00 sleep paralysis episodes per week
Standard Deviation 1.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy
Baseline
|
51.57 score on a scale
Standard Deviation 7.87
|
49.83 score on a scale
Standard Deviation 4.74
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy
Posttreatment
|
53.97 score on a scale
Standard Deviation 5.74
|
50.17 score on a scale
Standard Deviation 6.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
Baseline
|
35.77 score on a scale
Standard Deviation 3.72
|
40.53 score on a scale
Standard Deviation 1.44
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
Posttreatment
|
40.60 score on a scale
Standard Deviation 2.95
|
43.13 score on a scale
Standard Deviation 3.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Nightmare Disorder Index
Posttreatment
|
8.33 score on a scale
Standard Deviation 1.15
|
7.33 score on a scale
Standard Deviation 1.15
|
|
Nightmare Disorder Index
Baseline
|
13.33 score on a scale
Standard Deviation 1.53
|
11.00 score on a scale
Standard Deviation 1.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Epworth Sleepiness Scale
Baseline
|
14.33 score on a scale
Standard Deviation 4.04
|
19.00 score on a scale
Standard Deviation 5.00
|
|
Epworth Sleepiness Scale
Posttreatment
|
14.00 score on a scale
Standard Deviation 3.61
|
18.33 score on a scale
Standard Deviation 5.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Hypersomnia Severity Index
Baseline
|
28.67 score on a scale
Standard Deviation 5.13
|
23.00 score on a scale
Standard Deviation 4.00
|
|
Hypersomnia Severity Index
Posttreatment
|
25.00 score on a scale
Standard Deviation 6.08
|
21.33 score on a scale
Standard Deviation 6.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Functional Outcomes of Sleep Questionnaire-10
Baseline
|
10.78 score on a scale
Standard Deviation 3.91
|
10.44 score on a scale
Standard Deviation 1.59
|
|
Functional Outcomes of Sleep Questionnaire-10
Posttreatment
|
12.72 score on a scale
Standard Deviation 1.58
|
11.17 score on a scale
Standard Deviation 2.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Paris Arousal Disorders Severity Scale
Posttreatment
|
10.00 score on a scale
Standard Deviation 1.00
|
6.33 score on a scale
Standard Deviation 5.51
|
|
Paris Arousal Disorders Severity Scale
Baseline
|
19.33 score on a scale
Standard Deviation 2.31
|
9.67 score on a scale
Standard Deviation 4.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
The Lucid Dream Skills Questionnaire (LUSK) measures the frequency of lucid dreaming. The LUSK total score ranges from 0-4 (the mean of the item scores), with higher scores representing a higher frequency of lucid dreaming. In general, a higher frequency of lucid dreaming is not inherently "better" or "worse." For the purpose of this trial, one of the intervention components (Targeted Dream Control) attempted to increase lucid dreaming, so a higher score for this trial would indicate an improvement.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Lucid Dream Skills Questionnaire (LUSK)
Baseline
|
1.30 score on a scale
Standard Deviation 1.30
|
1.37 score on a scale
Standard Deviation 0.74
|
|
Lucid Dream Skills Questionnaire (LUSK)
Posttreatment
|
1.27 score on a scale
Standard Deviation 1.36
|
1.53 score on a scale
Standard Deviation 0.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and posttreatment (up to 13 weeks)Population: Completed participants were included in analysis.
Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions.
Outcome measures
| Measure |
Imagery Rehearsal Therapy (IRT)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 Participants
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
|---|---|---|
|
Dream Delusions Scale
Baseline
|
5.00 score on a scale
Standard Deviation 1.00
|
1.67 score on a scale
Standard Deviation 2.89
|
|
Dream Delusions Scale
Posttreatment
|
2.67 score on a scale
Standard Deviation 1.53
|
1.00 score on a scale
Standard Deviation 1.73
|
Adverse Events
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Imagery Rehearsal Therapy (IRT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC)
n=3 participants at risk
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream control: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
|
Imagery Rehearsal Therapy (IRT)
n=3 participants at risk
Participants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy: Therapy to reduce nightmares, delivered via videoconference sessions
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Twisted ankle
|
0.00%
0/3 • 11-13 weeks
|
33.3%
1/3 • Number of events 1 • 11-13 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place