Mental Imagery and Targeted Memory Reactivation in Insomnia
NCT ID: NCT06335784
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-04-22
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Sleep Hygiene + Odor
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 intervention
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 (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.
Sleep Hygiene
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 bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention
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)
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.
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.
"Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention
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)
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.
Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep
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.
"Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention
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.
Interventions
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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.
Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep
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 Hygiene
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 + Odor
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 intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
No
Sponsors
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University of Geneva, Switzerland
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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Lampros Perogamvros
Attending Physician
Locations
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Center for Sleep Medicine
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-00456
Identifier Type: -
Identifier Source: org_study_id
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