Narcolepsy, Narcolepsy Type 1, Narcolepsy Type 2, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Conditions
Brief summary
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: * Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares? * Does adding targeted dream control (TDC) to IRT make it more effective? Participants will be randomized to one of two treatment groups and will be asked to: * Complete a daily log of sleep symptoms for up to 13 weeks. * Attend 7 sessions of treatment. * Complete questionnaires before and after treatment. * Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).
Interventions
BEHAVIORALImagery rehearsal therapy
Therapy to reduce nightmares, delivered via videoconference sessions
BEHAVIORALTargeted dream control
Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(all participants): * Diagnosis of narcolepsy * Age 18 or older * Speak English * Live in the United States * Receiving standard medical care for narcolepsy * Sleep and psychiatric medications stable for at least 3 months * Nightmare frequency of ≥3 times per week * Nightmare Disorder Index score indicates probable nightmare disorder Inclusion Criteria (Chicago area participants): * Able to attend a study appointment in Evanston, IL * Able and willing to not take wake-promoting medications on day of lab visit
Exclusion criteria
* History of a neurological disorder that might alter EEG * Currently engaged in sleep- or trauma-focused psychotherapy * Previous behavioral treatment for nightmares * Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment * Untreated sleep apnea (AHI ≥ 5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nightmare Frequency | Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11) | Frequency of nightmares as measured by daily diary |
| Disturbing Dream and Nightmare Severity Scale | Baseline and posttreatment (up to 13 weeks) | Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | Baseline and posttreatment (up to 13 weeks) | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale | Baseline and posttreatment (up to 13 weeks) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Mundt, PhD
Northwestern University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 1 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
None listed