Combined Treatment of Nightmares With Targeted Memory Reactivation and Imagery Rehearsal Therapy
The Nightmare Catcher: Modulating Dreams With Targeted Memory Reactivation
1 other identifier
interventional
36
1 country
1
Brief Summary
With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of nightmare disorder. This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with nightmare disorder are asked to perform an initial IRT session and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound (TMR group), while no such pairing with a sound takes place for the other half (control group). During the next two weeks, all patients perform IRT every evening at home and are exposed to the sound during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the severity of nightmares before and after (2-weeks follow-up and 3-months follow-up) this intervention takes place using the validated Nightmare Frequency Questionnaire (NFQ, primary outcome measure), which retrospectively identifies the frequency of nightmares. We hypothesize that patients treated with IRT and who are exposed, during REM sleep and over 14 nights, to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of nightmares compared to participants with stimulation of the same, but non-associated, sound during REM sleep (control group).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFirst Submitted
Initial submission to the registry
February 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedFebruary 14, 2022
February 1, 2022
2 years
February 2, 2022
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Nightmare Frequency Questionnaire (NFQ)
Validated self-report scale to assess the number of nightmares per week
2 weeks
Nightmare Frequency Questionnaire (NFQ)
Validated self-report scale to assess the number of nightmares per week
3 months
Secondary Outcomes (8)
Nightmare Distress Questionnaire (NDQ)
2 weeks
Beck Depression Inventory (BDI-II)
2 weeks
Pittsburgh Sleep Quality Index (PSQI)
2 weeks
Proportion of the emotion 'joy' in dreams
2 weeks
Proportion of the emotion 'fear' in dreams
2 weeks
- +3 more secondary outcomes
Study Arms (2)
TMR group
EXPERIMENTALPatients will receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT). They will also receive the sound during REM sleep.
Control group
ACTIVE COMPARATORPatients will not receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT). They will receive the same sound as the experimental group during REM sleep under the same conditions.
Interventions
Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories. By using targeted memory reactivation (TMR), a known method where we associate a sound with a waking experience (i.e., a positive outcome of imagery rehearsal therapy in this study) and strengthening it during REM sleep, we want to accelerate the remission of nightmares.
These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.
Eligibility Criteria
You may qualify if:
- Diagnosis of nightmare disorder according to the International Classification of Sleep Disorders (ICSD-3) diagnostic and coding manual
- Patients with at least moderate severity (\>1 episode per week)
You may not qualify if:
- severe depression
- insomnia disorder
- psychosis or anxiety disorder
- other sleep disorder (e.g.,obstructive sleep apnea syndrome, restless legs syndrome)
- neurological disease
- use of medications that would be likely to produce nightmares (e.g. hypnotics, β-blockers, amphetamines, antimicrobial agents)
- use of anxiolytics, antipsychotic or antidepressant medication were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Sleep Medicine, University Hospitals of Geneva
Geneva, 1225, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Clinical Fellow
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 14, 2022
Study Start
February 1, 2020
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
February 14, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share