Insomnia DisorderNCT06335784
Mental Imagery and Targeted Memory Reactivation in Insomnia
A study testing Imagery Rescripting (IR), Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep and Sleep Hygiene in people with Insomnia Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Imagery Rescripting (IR), Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Apr 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years
- Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3)
- ISI > 10
- PSQI > 5
- No other current treatment for Insomnia
Who cannot join
- patients with another psychiatric disorder requiring acute treatment according to DSM-5
- patients with medical (e.g. neurological disorders) or other disorders explaining the predominant complaint of insomnia (e.g., sleep apneas with ODI>15/h, restless legs syndrome, periodic limb movements with PLM>15, chronic pain)
- patients with significant substance use/withdrawal
- patients with heavy smoking
- known pregnancy
- patients suffering from anosmia, olfactory related issues and respiratory pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Center for Sleep Medicine
Geneva
Lampros Perogamvros, +41223729946, Lampros.Perogamvros@hcuge.ch
Lampros Perogamvros
About this study
In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).
Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.
Read more
Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).
At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.
The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.
- Conditions
- Insomnia Disorder
- Being tested
- Imagery Rescripting (IR), Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep, Sleep Hygiene, Sleep Hygiene + Odor, "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention
- Keywords
- Insomnia, Odors, Imagery, TMR
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rescripting (IR)Behavioural
Imagery rescripting (IR) is a technique where the individual is instructed to imagine a negative memory or image as vividly as possible, and to change it in a direction that he/she desires. IR seems particularly efficient because it is based on the experienced emotions during perceptual information processing, thereby eliciting stronger emotional responses than verbal processing.
Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleepBehavioural
Targeted Memory Reactivation (TMR) is a technique used to strengthen a memory trace during sleep. TMR is used to modify memory formation through the application of cues during sleep. In this TMR protocol, an olfactory cue is associated with the imagery rescripting (IR) during the day, and then administered during sleep. In that way, the replay of the associated memory and its corresponding neural representation in memory networks are artificially promoted, a procedure which usually strengthens memory consolidation. Previous studies have shown that TMR in sleep reduces emotional arousal, making it a promising technique for insomnia.
Sleep HygieneBehavioural
Sleep hygiene education includes modifications in the behavior (e.g., exercise, coffee, alcohol intake) and environment (e.g., light, noise, temperature conditions) that offer to the individual the foundation for healthy sleep. Sleep hygiene is an important component in treating ID, but insufficient and less effective than CBT-I when offered alone.
Sleep Hygiene + OdorBehavioural
Sleep hygiene instructions will be applied in the presence of an odor, which will be also used during the night.
"Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionOther
Rocking stimulation boosts brain oscillations in deep sleep (i.e., sleep spindles and slow oscillations) into a rhythmic appearance supporting a neurophysiological mechanism whereby continuous rocking entrains endogenous thalamo-cortical sleep oscillations. The beneficial effects of rocking strengthening the continuity of sleep might have clinical applications and it will be of interest to evaluate if such non-pharmacological could improve sleep and reduce such features of hyperarousal in ID patients.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene (SH) | Active comparator | Participants will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. Each session will consist of providing patients with advice to help their sleep without any CBT-I or other complementary medicine components. They will also have an odorless diffuser being diffused at the end of each weekly individual session and during the night. Receives: Behavioral: Sleep Hygiene; Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention |
| Imagery Rescripting (IR) | Experimental | Participants will receive 4 weekly individual sessions of IR. The IR technique consists of imagining a negative memory or image as vividly as possible, and of transforming it into a positive one. An odorless diffuser will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home, every day in bed and have the same odorless diffuser being diffused during the night. Receives: Behavioral: Imagery Rescripting (IR); Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention |
| Targeted Memory Reactivation (TMR) | Experimental | Participants will receive 4 weekly individual sessions of IR, at the end of which, a chosen odor will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home every day in bed and have the same odor being diffused during the night. Receives: Behavioral: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep; Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention |
| Odor Alone (OA) | Active comparator | Participants will have a chosen odor diffused during the night for 4 weeks and will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. The chosen odor will be diffused at the end of each weekly individual session. Receives: Behavioral: Sleep Hygiene + Odor; Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity.
Measured: Baseline, 5 Weeks and 3 Months
Secondary outcomes (7)
Pittsburgh sleep quality index (PSQI)
Validated self-report scale to assess the quality of sleep, the score ranges from 0-21, zero indicating no symptom severity and 21 indicating the higher symptom severity.
Measured: Baseline, 5 Weeks and 3 Months
Total Sleep Time (TST)
Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively.
Measured: Baseline and 5 Weeks
Wake After Sleep Onset (WASO)
Number of awakenings during the night. This outcome is measured both subjectively and objectively.
Measured: Baseline and 5 Weeks
Beck Depression Inventory II (BDI-II)
Validated self-report scale to assess depressive symptoms, the score ranges from 0-63, zero indicating no symptom severity and 63 indicating the higher symptom severity.
Measured: Baseline, 5 Weeks and 3 Months
State Trait Anxiety Inventory (STAI)
Validated self-report scale to assess anxiety, the score ranges from 20-80, 20 indicating no symptom severity and 80 indicating the higher symptom severity.
Measured: Baseline, 5 Weeks and 3 Months
Sleep efficiency (SE)
Ratio between total time spent in bed and total sleep time. This outcome is measured both subjectively and objectively.
Measured: Baseline and 5 Weeks
Micro-arousals
Objective measure of micro-awakenings during the night.
Measured: Baseline and 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start22 Apr 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, Lampros Perogamvros, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335784
- Sponsor's protocol ID
- 2023-00456
- Other IDs
- 2023
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Imagery and Targeted Memory Reactivation in Insomnia
- ClinicalTrials.gov ID
- NCT06335784
- Acronym / sponsor ID
- 2023-00456
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Odors, Imagery, TMR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Mar 2024 (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.
In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID).
Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night.
Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure).
At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night.
The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene (SH) | Active comparator | Behavioral: Sleep Hygiene, Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionParticipants will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. Each session will consist of providing patients with advice to help their sleep without any CBT-I or other complementary medicine components. They will also have an odorless diffuser being diffused at the end of each weekly individual session and during the night. |
| Imagery Rescripting (IR) | Experimental | Behavioral: Imagery Rescripting (IR), Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionParticipants will receive 4 weekly individual sessions of IR. The IR technique consists of imagining a negative memory or image as vividly as possible, and of transforming it into a positive one. An odorless diffuser will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home, every day in bed and have the same odorless diffuser being diffused during the night. |
| Targeted Memory Reactivation (TMR) | Experimental | Behavioral: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep, Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionParticipants will receive 4 weekly individual sessions of IR, at the end of which, a chosen odor will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home every day in bed and have the same odor being diffused during the night. |
| Odor Alone (OA) | Active comparator | Behavioral: Sleep Hygiene + Odor, Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionParticipants will have a chosen odor diffused during the night for 4 weeks and will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. The chosen odor will be diffused at the end of each weekly individual session. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 45 years
- Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3)
- ISI > 10
- PSQI > 5
- No other current treatment for Insomnia
Key exclusion criteria (6 listed)
- patients with another psychiatric disorder requiring acute treatment according to DSM-5
- patients with medical (e.g. neurological disorders) or other disorders explaining the predominant complaint of insomnia (e.g., sleep apneas with ODI>15/h, restless legs syndrome, periodic limb movements with PLM>15, chronic pain)
- patients with significant substance use/withdrawal
- patients with heavy smoking
- known pregnancy
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 Rescripting (IR)Imagery rescripting (IR) is a technique where the individual is instructed to imagine a negative memory or image as vividly as possible, and to change it in a direction that he/she desires. IR seems particularly efficient because it is based on the experienced emotions during perceptual information processing, thereby eliciting stronger emotional responses than verbal processing. | Behavioural | Imagery Rescripting (IR) |
| Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleepTargeted Memory Reactivation (TMR) is a technique used to strengthen a memory trace during sleep. TMR is used to modify memory formation through the application of cues during sleep. In this TMR protocol, an olfactory cue is associated with the imagery rescripting (IR) during the day, and then administered during sleep. In that way, the replay of the associated memory and its corresponding neural representation in memory networks are artificially promoted, a procedure which usually strengthens memory consolidation. Previous studies have shown that TMR in sleep reduces emotional arousal, making it a promising technique for insomnia. | Behavioural | Targeted Memory Reactivation (TMR) |
| Sleep HygieneSleep hygiene education includes modifications in the behavior (e.g., exercise, coffee, alcohol intake) and environment (e.g., light, noise, temperature conditions) that offer to the individual the foundation for healthy sleep. Sleep hygiene is an important component in treating ID, but insufficient and less effective than CBT-I when offered alone. | Behavioural | Sleep Hygiene (SH) |
| Sleep Hygiene + OdorSleep hygiene instructions will be applied in the presence of an odor, which will be also used during the night. | Behavioural | Odor Alone (OA) |
| "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the interventionRocking stimulation boosts brain oscillations in deep sleep (i.e., sleep spindles and slow oscillations) into a rhythmic appearance supporting a neurophysiological mechanism whereby continuous rocking entrains endogenous thalamo-cortical sleep oscillations. The beneficial effects of rocking strengthening the continuity of sleep might have clinical applications and it will be of interest to evaluate if such non-pharmacological could improve sleep and reduce such features of hyperarousal in ID patients. | Other | Imagery Rescripting (IR), Odor Alone (OA), Sleep Hygiene (SH), Targeted Memory Reactivation (TMR) |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline, 5 Weeks and 3 Months
Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity.
7 secondary outcomes
Pittsburgh sleep quality index (PSQI)
Time frame: Baseline, 5 Weeks and 3 Months
Total Sleep Time (TST)
Time frame: Baseline and 5 Weeks
Wake After Sleep Onset (WASO)
Time frame: Baseline and 5 Weeks
Beck Depression Inventory II (BDI-II)
Time frame: Baseline, 5 Weeks and 3 Months
State Trait Anxiety Inventory (STAI)
Time frame: Baseline, 5 Weeks and 3 Months
Sleep efficiency (SE)
Time frame: Baseline and 5 Weeks
Micro-arousals
Time frame: Baseline and 5 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Rescripting (IR), Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep and Sleep Hygiene in people with Insomnia Disorder, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lampros Perogamvros (+41223729946, Lampros.Perogamvros@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline, 5 Weeks and 3 Months). 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 3 Mar 2026.