NCT05933109

Brief Summary

With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of traumatic nightmares and post-traumatic stress disorder (PTSD) symptomatology. This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with PTSD are asked to perform 3 weekly IRT sessions and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound S1 (TMR group), while the other half is not exposed to this sound (control group). All patients will perform IRT every evening at home and will be exposed to the sound S1 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the severity of PTSD and nightmares before and after (1-month follow-up and 3-months follow-up) this intervention takes place using the validated Clinically Administered PTSD Scale for DSM-5 (CAPS-5, primary outcome measure). The investigators hypothesize that patients treated with IRT and who are exposed, during REM sleep to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of PTSD severity and 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
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2025

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

June 20, 2023

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinician-Administered PTSD Scale for DSM-5

    Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.

    1 month

  • Clinician-Administered PTSD Scale for DSM-5

    Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.

    3 months

Secondary Outcomes (12)

  • Nightmare Frequency

    1 month

  • Nightmare Frequency

    3 months

  • Nightmare Distress Questionnaire

    1 month

  • Nightmare Distress Questionnaire

    3 months

  • Positive emotions in dreams

    1 month

  • +7 more secondary outcomes

Other Outcomes (3)

  • Sleep efficiency

    1 month

  • REM arousal index

    1 month

  • Arousal index

    1 month

Study Arms (2)

TMR group

EXPERIMENTAL

Patients will receive a sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT). They will also receive the sound S1 during REM sleep.

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

Control group

ACTIVE COMPARATOR

Patients will not receive the sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT). During REM sleep, they will receive the same sound as the experimental group (S1) under the same conditions.

Behavioral: Imagery Rehearsal Therapy

Interventions

These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without association with the sound S1.

Control group

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 a sound S1 is associated with a waking experience (i.e., a positive outcome of imagery rehearsal therapy in this study) and strengthening it during REM sleep, the investigators want to accelerate the remission of traumatic nightmares and PTSD symptomatology.

TMR group

Eligibility Criteria

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

You may qualify if:

  • with untreated persistent PTSD according to DSM-5 (\> 1 month), suffering from chronic nightmares
  • with no active specific treatment for PTSD

You may not qualify if:

  • patients with active specific treatment for PTSD
  • patients with neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Sleep Medicine

Geneva, Switzerland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

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
Attending Physician

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 6, 2023

Study Start

March 1, 2023

Primary Completion

July 27, 2025

Study Completion

October 27, 2025

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations