- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05237778
Combined Treatment of Nightmares With Targeted Memory Reactivation and Imagery Rehearsal Therapy
February 11, 2022 updated by: Lampros Perogamvros, University Hospital, Geneva
The Nightmare Catcher: Modulating Dreams With Targeted Memory Reactivation
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geneva, Switzerland, 1225
- Center for Sleep Medicine, University Hospitals of Geneva
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: TMR group
Patients will receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT).
They will also receive the sound during REM sleep.
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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.
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Active Comparator: Control group
Patients 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.
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These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nightmare Frequency Questionnaire (NFQ)
Time Frame: 2 weeks
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Validated self-report scale to assess the number of nightmares per week
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2 weeks
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Nightmare Frequency Questionnaire (NFQ)
Time Frame: 3 months
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Validated self-report scale to assess the number of nightmares per week
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nightmare Distress Questionnaire (NDQ)
Time Frame: 2 weeks
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Validated self-report scale to assess the emotional disturbance attributed to the nightmares
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2 weeks
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Beck Depression Inventory (BDI-II)
Time Frame: 2 weeks
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Validated self-report scale to assess depressive symptoms
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2 weeks
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 2 weeks
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Validated self-report scale to assess the quality of sleep
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2 weeks
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Proportion of the emotion 'joy' in dreams
Time Frame: 2 weeks
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Use of a dream diary
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2 weeks
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Proportion of the emotion 'fear' in dreams
Time Frame: 2 weeks
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Use of a dream diary
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2 weeks
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Nightmare Distress Questionnaire (NDQ)
Time Frame: 3 months
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Validated self-report scale to assess the emotional disturbance attributed to the nightmares
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3 months
|
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Beck Depression Inventory (BDI-II)
Time Frame: 3 months
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Validated self-report scale to assess depressive symptoms
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3 months
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 3 months
|
Validated self-report scale to assess the quality of sleep
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2019-02270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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