Nightmares, REM-Sleep TypeNCT05237778
Combined Treatment of Nightmares With Targeted Memory Reactivation and Imagery Rehearsal Therapy
A study testing Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep and Imagery Rehearsal Therapy in people with Nightmares, REM-Sleep Type, run by University Hospital, Geneva at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nightmares, REM-Sleep Type
- What is being tested?
- Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep and Imagery Rehearsal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Sleep Medicine, University Hospitals of Geneva
Geneva, 1225
About this study
Official title: 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).
- Conditions
- Nightmares, REM-Sleep Type
- Being tested
- Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep, Imagery Rehearsal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleepBehavioural
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 TherapyBehavioural
These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Imagery Rehearsal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare Frequency Questionnaire (NFQ)
Validated self-report scale to assess the number of nightmares per week
Measured: 2 weeks
Nightmare Frequency Questionnaire (NFQ)
Validated self-report scale to assess the number of nightmares per week
Measured: 3 months
Secondary outcomes (8)
Nightmare Distress Questionnaire (NDQ)
Validated self-report scale to assess the emotional disturbance attributed to the nightmares
Measured: 2 weeks
Beck Depression Inventory (BDI-II)
Validated self-report scale to assess depressive symptoms
Measured: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
Validated self-report scale to assess the quality of sleep
Measured: 2 weeks
Proportion of the emotion 'joy' in dreams
Use of a dream diary
Measured: 2 weeks
Proportion of the emotion 'fear' in dreams
Use of a dream diary
Measured: 2 weeks
Nightmare Distress Questionnaire (NDQ)
Validated self-report scale to assess the emotional disturbance attributed to the nightmares
Measured: 3 months
Beck Depression Inventory (BDI-II)
Validated self-report scale to assess depressive symptoms
Measured: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Validated self-report scale to assess the quality of sleep
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Feb 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nightmares, REM-Sleep TypeStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lampros Perogamvros, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237778
- Sponsor's protocol ID
- 2019-02270
- Other IDs
- 2019
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nightmare Catcher: Modulating Dreams With Targeted Memory Reactivation
- ClinicalTrials.gov ID
- NCT05237778
- Acronym / sponsor ID
- 2019-02270
- Conditions
- Nightmares, REM-Sleep Type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMR group | Experimental | Behavioral: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleepPatients will receive a sound while they generate a positive outcome of imagery rehearsal therapy (IRT). They will also receive the sound during REM sleep. |
| Control group | Active comparator | Behavioral: Imagery Rehearsal TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- severe depression
- insomnia disorder
- psychosis or anxiety disorder
- other sleep disorder (e.g.,obstructive sleep apnea syndrome, restless legs syndrome)
- neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleepEmerging 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. | Behavioural | TMR group |
| Imagery Rehearsal TherapyThese patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound. | Behavioural | Control group |
Primary outcome
Nightmare Frequency Questionnaire (NFQ)
Time frame: 2 weeks
Validated self-report scale to assess the number of nightmares per week
Nightmare Frequency Questionnaire (NFQ)
Time frame: 3 months
Validated self-report scale to assess the number of nightmares per week
8 secondary outcomes
Nightmare Distress Questionnaire (NDQ)
Time frame: 2 weeks
Beck Depression Inventory (BDI-II)
Time frame: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 weeks
Proportion of the emotion 'joy' in dreams
Time frame: 2 weeks
Proportion of the emotion 'fear' in dreams
Time frame: 2 weeks
Nightmare Distress Questionnaire (NDQ)
Time frame: 3 months
Beck Depression Inventory (BDI-II)
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep and Imagery Rehearsal Therapy in people with Nightmares, REM-Sleep Type, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightmare Frequency Questionnaire (NFQ) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.