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The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:
Participants will be randomized to one of two treatment groups and will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagery rehearsal therapy (IRT) | Experimental | Participants randomized to this group will receive 7 sessions of IRT. |
|
| Imagery rehearsal therapy and targeted dream control (IRT+TDC) | Experimental | Participants randomized to this group will receive 7 sessions of IRT+TDC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagery rehearsal therapy | Behavioral | Therapy to reduce nightmares, delivered via videoconference sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nightmare Frequency | Frequency of nightmares as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Disturbing Dream and Nightmare Severity Scale | Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares. | Baseline and posttreatment (up to 13 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | 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. | Baseline and posttreatment (up to 13 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Dream Enactment Frequency | Frequency of dream enactment as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Sleep Talking Frequency |
Inclusion Criteria (all participants):
Inclusion Criteria (Chicago area participants):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Mundt, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Completed participants included
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only data for completed participants were analyzed for the manuscript. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nightmare Frequency | Frequency of nightmares as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | nightmares per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
11-13 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Twisted ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Mundt | Northwestern University | 312-503-2846 | jennifer.mundt@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2024 | Oct 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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|
| Targeted dream control | Behavioral | 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 |
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. |
| Baseline and posttreatment (up to 13 weeks) |
Frequency of sleep talking as measured by daily diary
| Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Lucid Dreams Without Control Frequency | Frequency of lucid dreams without control as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Lucid Dreams With Control Frequency | Frequency of lucid dreams with control as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Sleep-related Hallucinations Frequency | Frequency of sleep-related hallucinations as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Sleep Paralysis Frequency | Frequency of sleep paralysis as measured by daily diary | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
| Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy | 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. | Baseline and posttreatment (up to 13 weeks) |
| Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms | 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. | Baseline and posttreatment (up to 13 weeks) |
| Nightmare Disorder Index | Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares. | Baseline and posttreatment (up to 13 weeks) |
| Epworth Sleepiness Scale | Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness. | Baseline and posttreatment (up to 13 weeks) |
| Hypersomnia Severity Index | Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms. | Baseline and posttreatment (up to 13 weeks) |
| Functional Outcomes of Sleep Questionnaire-10 | Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning. | Baseline and posttreatment (up to 13 weeks) |
| Paris Arousal Disorders Severity Scale | Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms. | Baseline and posttreatment (up to 13 weeks) |
| Lucid Dream Skills Questionnaire (LUSK) | 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. | Baseline and posttreatment (up to 13 weeks) |
| Dream Delusions Scale | Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions. | Baseline and posttreatment (up to 13 weeks) |
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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Disturbing Dream and Nightmare Severity Scale | Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | 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. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale | 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. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Dream Enactment Frequency | Frequency of dream enactment as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | dream enactment episodes per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Sleep Talking Frequency | Frequency of sleep talking as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | sleep talking episodes per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Lucid Dreams Without Control Frequency | Frequency of lucid dreams without control as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | episodes per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Lucid Dreams With Control Frequency | Frequency of lucid dreams with control as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | episodes per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Sleep-related Hallucinations Frequency | Frequency of sleep-related hallucinations as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | sleep-related hallucinations per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Sleep Paralysis Frequency | Frequency of sleep paralysis as measured by daily diary | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | sleep paralysis episodes per week | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) |
|
|
|
| Other Pre-specified | Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy | 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. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms | 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. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Nightmare Disorder Index | Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Epworth Sleepiness Scale | Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Hypersomnia Severity Index | Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Functional Outcomes of Sleep Questionnaire-10 | Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Paris Arousal Disorders Severity Scale | Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Lucid Dream Skills Questionnaire (LUSK) | 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. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
|
|
| Other Pre-specified | Dream Delusions Scale | Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions. | Completed participants were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and posttreatment (up to 13 weeks) |
|
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|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |