NarcolepsyDAWNNCT06383806
Decreasing Nightmares in Adults With Narcolepsy
A study testing Imagery Rehearsal Therapy (IRT) in people with Narcolepsy and Narcolepsy Type 1, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy
- What is being tested?
- Imagery Rehearsal Therapy (IRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of narcolepsy type 1 or narcolepsy type 2
- Nightmare frequency of ≥1 times per week
- Age 18 or older
- Able to speak, read, and write in English
- Live in the United States
- Sleep and psychiatric medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study
Show all 10Show fewer
- Live with a romantic partner who meets the above criteria and has agreed to participate in the study
- Age 18 or older
- Able to speak, read, and write in English
- Live in the United States
Who cannot join
- Currently engaged in trauma- or sleep-related psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated moderate-severe sleep apnea
- PARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Jennifer Mundt, PhD, 801-646-8287, DAWNstudy@utah.edu
About this study
Official title: Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy, Nightmare, Nightmare Disorder With Associated Other Sleep Disorder
- Being tested
- Imagery Rehearsal Therapy (IRT)
- Keywords
- Imagery Rehearsal Therapy, Cognitive Behavioral Therapy for Nightmares
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rehearsal Therapy (IRT)Behavioural
Also called Cognitive Behavioral Therapy for Nightmares (CBT-N)
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. During the sessions, participants will learn techniques for managing and changing nightmares.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Treatment arm will receive the intervention immediately following the first assessment. Receives: Behavioral: Imagery Rehearsal Therapy (IRT) |
| Waitlist | Other | The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment. Receives: Behavioral: Imagery Rehearsal Therapy (IRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disturbing Dream and Nightmare Severity Index (DDNSI)
The DDNSI is a questionnaire which measures the severity of nightmares.
Measured: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Nightmare frequency (sleep diary)
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
Measured: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Secondary outcomes (2)
PROMIS Anxiety
Questionnaire which measures the severity of anxiety symptoms.
Measured: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
PROMIS Depression
Questionnaire which measures the severity of depressive symptoms.
Measured: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jul 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mundt, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383806
- Sponsor's protocol ID
- IRB_00188162
- Other IDs
- 372-SR-25
- Acronym
- DAWN
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06383806
- Acronym / sponsor ID
- DAWN / IRB_00188162
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy, Nightmare, Nightmare Disorder With Associated Other Sleep Disorder
- Keywords
- Imagery Rehearsal Therapy, Cognitive Behavioral Therapy for Nightmares
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Imagery Rehearsal Therapy (IRT)The Treatment arm will receive the intervention immediately following the first assessment. |
| Waitlist | Other | Behavioral: Imagery Rehearsal Therapy (IRT)The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of narcolepsy type 1 or narcolepsy type 2
- Nightmare frequency of ≥1 times per week
- Age 18 or older
- Able to speak, read, and write in English
- Live in the United States
Key exclusion criteria (5 listed)
- Currently engaged in trauma- or sleep-related psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated moderate-severe sleep apnea
- PARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Rehearsal Therapy (IRT)Also: Cognitive Behavioral Therapy for Nightmares (CBT-N)The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. During the sessions, participants will learn techniques for managing and changing nightmares. | Behavioural | Treatment, Waitlist |
Primary outcome
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
The DDNSI is a questionnaire which measures the severity of nightmares.
Nightmare frequency (sleep diary)
Time frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
2 secondary outcomes
PROMIS Anxiety
Time frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
PROMIS Depression
Time frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Narcolepsy
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rehearsal Therapy (IRT) in people with Narcolepsy and Narcolepsy Type 1, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Mundt, PhD (801-646-8287, DAWNstudy@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disturbing Dream and Nightmare Severity Index (DDNSI) (time frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.