Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335784
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-21
Brief Title:
Mental Imagery and Targeted Memory Reactivation in Insomnia
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Mental Imagery and Targeted Memory Reactivation in Insomnia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sessionweek 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 eg 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
Patients with ID will be randomized into four groups in the first group SH group patients will have 4 weekly sessions 1 sessionweek 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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None