NCT06335784 Mental Imagery and Targeted Memory Reactivation in Insomnia
| NCT ID | NCT06335784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-22 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06335784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06335784 currently recruiting?
Yes, NCT06335784 is actively recruiting participants. Contact the research team at Lampros.Perogamvros@hcuge.ch for enrollment information.
Where is the NCT06335784 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT06335784 clinical trial?
NCT06335784 is sponsored by University Hospital, Geneva. The trial plans to enroll 120 participants.
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