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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05237778
Other study ID # 2019-02270
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date January 31, 2022

Study information

Verified date February 2022
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep
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.
Imagery Rehearsal Therapy
These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.

Locations

Country Name City State
Switzerland Center for Sleep Medicine, University Hospitals of Geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

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
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