NCT05237778

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 2, 2022

Last Update Submit

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

EXPERIMENTAL

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.

Behavioral: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep

Control group

ACTIVE COMPARATOR

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.

Behavioral: Imagery Rehearsal Therapy

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.

TMR group

These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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

Locations