Nightmares, REM-Sleep Type Clinical Trial
Official title:
The Nightmare Catcher: Modulating Dreams With Targeted Memory Reactivation
Verified date | February 2022 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 36 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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, ß-blockers, amphetamines, antimicrobial agents) - use of anxiolytics, antipsychotic or antidepressant medication were excluded. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Center for Sleep Medicine, University Hospitals of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nightmare Frequency Questionnaire (NFQ) | Validated self-report scale to assess the number of nightmares per week | 2 weeks | |
Primary | Nightmare Frequency Questionnaire (NFQ) | Validated self-report scale to assess the number of nightmares per week | 3 months | |
Secondary | Nightmare Distress Questionnaire (NDQ) | Validated self-report scale to assess the emotional disturbance attributed to the nightmares | 2 weeks | |
Secondary | Beck Depression Inventory (BDI-II) | Validated self-report scale to assess depressive symptoms | 2 weeks | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Validated self-report scale to assess the quality of sleep | 2 weeks | |
Secondary | Proportion of the emotion 'joy' in dreams | Use of a dream diary | 2 weeks | |
Secondary | Proportion of the emotion 'fear' in dreams | Use of a dream diary | 2 weeks | |
Secondary | Nightmare Distress Questionnaire (NDQ) | Validated self-report scale to assess the emotional disturbance attributed to the nightmares | 3 months | |
Secondary | Beck Depression Inventory (BDI-II) | Validated self-report scale to assess depressive symptoms | 3 months | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Validated self-report scale to assess the quality of sleep | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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