Center for Sleep Medicine
Geneva, Switzerland
Location status: Recruiting
Location contact
Lampros Perogamvros
CONTACT
Lampros Perogamvros
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06335784
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Geneva, Switzerland
Location status: Recruiting
Lampros Perogamvros
CONTACT
Lampros Perogamvros
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 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 instructions will be applied in the presence of an odor, which will be also used during the night.
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.
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.
Time frame: Baseline, 5 Weeks and 3 Months
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.
Time frame: Baseline and 5 Weeks
Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively.
Time frame: Baseline and 5 Weeks
Number of awakenings during the night. This outcome is measured both subjectively and objectively.
Time frame: Baseline, 5 Weeks and 3 Months
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.
Time frame: Baseline, 5 Weeks and 3 Months
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.
Time frame: Baseline and 5 Weeks
Ratio between total time spent in bed and total sleep time. This outcome is measured both subjectively and objectively.
Time frame: Baseline and 5 Weeks
Objective measure of micro-awakenings during the night.
Time frame: Baseline and 5 Weeks
A 240-item self-administered questionnaire designed to measure 4 temperament and 3 character scales.
Time frame: Baseline and 5 Weeks
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.
Time frame: Baseline and 5 Weeks
A 12-item self-reported questionnaire designed to measure arousability
Time frame: Baseline and 5 Weeks
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"
Time frame: Baseline and 5 Weeks
A sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus.
Time frame: Baseline and 5 Weeks
Subjects will be instructed to learn 46 word-pairs with an immediate (pre-sleep) and a delayed one (post-sleep) to assess overnight improvement
Time frame: Baseline and 5 Weeks
A 40-item self-reported questionnaire designed to measure attachment style.
Contact information is provided by the study sponsor or research team.
Kevin Mammeri
CONTACT
Lampros Perogamvros
CONTACT
University Hospital, Geneva
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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