- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335784
Mental Imagery and Targeted Memory Reactivation in Insomnia
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lampros Perogamvros
- Phone Number: +41223729946
- Email: Lampros.Perogamvros@hcuge.ch
Study Contact Backup
- Name: Kevin Mammeri
- Phone Number: +33627694534
- Email: Kevin.Mammeri@unige.ch
Study Locations
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Geneva, Switzerland
- Recruiting
- Center for Sleep Medicine
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Contact:
- Lampros Perogamvros
- Phone Number: +41223729946
- Email: Lampros.Perogamvros@hcuge.ch
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Principal Investigator:
- Lampros Perogamvros
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sleep Hygiene (SH)
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.
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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.
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.
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Experimental: Imagery Rescripting (IR)
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.
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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.
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.
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Experimental: Targeted Memory Reactivation (TMR)
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.
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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.
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.
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Active Comparator: Odor Alone (OA)
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.
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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.
Sleep hygiene instructions will be applied in the presence of an odor, which will be also used during the night.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI)
Time Frame: Baseline, 5 Weeks and 3 Months
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Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity.
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Baseline, 5 Weeks and 3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh sleep quality index (PSQI)
Time Frame: Baseline, 5 Weeks and 3 Months
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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.
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Baseline, 5 Weeks and 3 Months
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Total Sleep Time (TST)
Time Frame: Baseline and 5 Weeks
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Time from sleep onset to sleep offset.
This outcome is measured both subjectively and objectively.
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Baseline and 5 Weeks
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Wake After Sleep Onset (WASO)
Time Frame: Baseline and 5 Weeks
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Number of awakenings during the night.
This outcome is measured both subjectively and objectively.
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Baseline and 5 Weeks
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Beck Depression Inventory II (BDI-II)
Time Frame: Baseline, 5 Weeks and 3 Months
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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.
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Baseline, 5 Weeks and 3 Months
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State Trait Anxiety Inventory (STAI)
Time Frame: Baseline, 5 Weeks and 3 Months
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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.
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Baseline, 5 Weeks and 3 Months
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Sleep efficiency (SE)
Time Frame: Baseline and 5 Weeks
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Ratio between total time spent in bed and total sleep time.
This outcome is measured both subjectively and objectively.
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Baseline and 5 Weeks
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Micro-arousals
Time Frame: Baseline and 5 Weeks
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Objective measure of micro-awakenings during the night.
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Baseline and 5 Weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperament and Character Inventory
Time Frame: Baseline and 5 Weeks
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A 240-item self-administered questionnaire designed to measure 4 temperament and 3 character scales.
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Baseline and 5 Weeks
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Pre-sleep Arousal Scale (PSAS)
Time Frame: Baseline and 5 Weeks
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A 16-item self-reported questionnaire designed to measure pre-sleep arousability, the score ranges from 16-80, 16 indicating no symptom severity and 80 indicating the higher symptom severity.
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Baseline and 5 Weeks
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Arousal Predisposition Scale (APS)
Time Frame: Baseline and 5 Weeks
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A 12-item self-reported questionnaire designed to measure arousability
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Baseline and 5 Weeks
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Digit Span Task
Time Frame: Baseline and 5 Weeks
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A working memory task, asking the participant to repeat a string of numbers which are displayed verbally, exactly as given, for "digits forward," and in reverse order for "digits backward"
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Baseline and 5 Weeks
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Psychomotor Vigilance Task (PVT)
Time Frame: Baseline and 5 Weeks
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A sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus.
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Baseline and 5 Weeks
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Declarative word paired-associate learning task
Time Frame: Baseline and 5 Weeks
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Subjects will be instructed to learn 46 word-pairs with an immediate (pre-sleep) and a delayed one (post-sleep) to assess overnight improvement
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Baseline and 5 Weeks
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Attachment Style Questionnaire (ASQ)
Time Frame: Baseline and 5 Weeks
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A 40-item self-reported questionnaire designed to measure attachment style.
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Baseline and 5 Weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-00456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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