Mental Imagery and Targeted Memory Reactivation in Insomnia

Insomnia Disorder Clinical Trial

Official title:

Mental Imagery and Targeted Memory Reactivation in Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335784
• Other study ID #: 2023-00456
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: Lampros Perogamvros
• Phone: +41223729946
• Email: Lampros.Perogamvros[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Other:
• "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.

Locations

Country	Name	City	State
Switzerland	Center for Sleep Medicine	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temperament and Character Inventory	A 240-item self-administered questionnaire designed to measure 4 temperament and 3 character scales.	Baseline and 5 Weeks
Other	Pre-sleep Arousal Scale (PSAS)	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.	Baseline and 5 Weeks
Other	Arousal Predisposition Scale (APS)	A 12-item self-reported questionnaire designed to measure arousability	Baseline and 5 Weeks
Other	Digit Span Task	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"	Baseline and 5 Weeks
Other	Psychomotor Vigilance Task (PVT)	A sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus.	Baseline and 5 Weeks
Other	Declarative word paired-associate learning task	Subjects will be instructed to learn 46 word-pairs with an immediate (pre-sleep) and a delayed one (post-sleep) to assess overnight improvement	Baseline and 5 Weeks
Other	Attachment Style Questionnaire (ASQ)	A 40-item self-reported questionnaire designed to measure attachment style.	Baseline and 5 Weeks
Primary	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.	Baseline, 5 Weeks and 3 Months
Secondary	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.	Baseline, 5 Weeks and 3 Months
Secondary	Total Sleep Time (TST)	Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively.	Baseline and 5 Weeks
Secondary	Wake After Sleep Onset (WASO)	Number of awakenings during the night. This outcome is measured both subjectively and objectively.	Baseline and 5 Weeks
Secondary	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.	Baseline, 5 Weeks and 3 Months
Secondary	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.	Baseline, 5 Weeks and 3 Months
Secondary	Sleep efficiency (SE)	Ratio between total time spent in bed and total sleep time. This outcome is measured both subjectively and objectively.	Baseline and 5 Weeks
Secondary	Micro-arousals	Objective measure of micro-awakenings during the night.	Baseline and 5 Weeks