The Impact of Attentive System on Sleep Reactivity (SREEG)

The Impact of Attentive System on Sleep Reactivity: a Study with a Participant-applied Electroencephalography in the Home Environment

Sleep Reactivity is defined as the degree to which a given amount of stress disrupts the sleep system, and it is consistent over time and across different type of stimuli. Sleep reactivity is a normal phenomenon under a certain threshold, but when it exceeds physiological threshold, this can lead to sleep disturbances that persist even following the removal of the stressor. Indeed, higher levels of sleep reactivity are associated to sleep quality depletion (i.e., increased sleep latency, reduced sleep efficiency and increased sleep fragmentation). The contribution of sleep reactivity in insomnia could be also related to altered (rapid eyes movement (REM)) REM sleep, since it plays a fundamental role in the elaboration of emotional and stressful stimuli, promoting a readjustment of the cognitive-emotional system. Hence, an alteration of REM after a stressor may prevent its proper processing and promote the disorder.

In order to, investigate this relationship this project aims to manipulate sleep reactivity to assess the differences between insomniacs and healthy controls, taking into account their attentional shifting performance and focusing on non-REM and REM sleep alterations.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia Due to Anxiety and Fear
• Intervention / Treatment: Behavioral: trauma film paradigm

Detailed Description

Among sleep disorders, insomnia is the most common, with a prevalence around 10%. It is a debilitating disorder characterized by complaints of difficulty with sleep initiation, duration, consolidation, or quality, that occurs despite adequate opportunity for sleep, and that results in daytime impairment (i.e., fatigue, daytime sleepiness, mood disorders, cognitive deficits). For the diagnosis of chronic insomnia these symptoms need to occur at least three times a week for at least three months. Its precise etiology is still unknown and widely debated. One of the most valid hypotheses proposed is the hyperarousal model of insomnia. As insomnia is the result of predisposing, precipitating factors and perpetuating factors, this model asserts that one of these factors include an increased arousal (somatic, cognitive, and cortical activation). Subjects with an altered state of arousal tend to cognitively focus on their sleep problem or general distressful events through a mechanism known as rumination. Rumination contributes to strengthen ''learned sleep preventing associations''. Therefore, in this context is important to clarify the role of stress in impacting sleep. It's known that a single stressor can elicit different reactions across individuals, and this concern the wakefulness as well as sleep. For this reason, in sleep research contexts increasing attention is given to the construct of Sleep Reactivity.

Sleep Reactivity is defined as the degree to which a given amount of stress disrupts the sleep system, and it is consistent over time and across different type of stimuli. Sleep reactivity is a normal phenomenon under a certain threshold, but when it exceeds physiological threshold, this can lead to sleep disturbances that persist even following the removal of the stressor. Indeed, higher levels of sleep reactivity are associated to sleep quality depletion (i.e., increased sleep latency, reduced sleep efficiency and increased sleep fragmentation). The contribution of sleep reactivity in insomnia could be also related to altered (rapid eyes movement (REM)) REM sleep, since it plays a fundamental role in the elaboration of emotional and stressful stimuli, promoting a readjustment of the cognitive-emotional system. Hence, an alteration of REM after a stressor may prevent its proper processing and promote the disorder.

Moreover, the AIE (Attention-Intention-Effort) pathway model describe the fundamental role of attention during the falling asleep process. According to the model, healthy sleep is an automatic and involuntary process, and it can be inhibited by selectively directing attention to it. Thus, focusing on sleep promotes the development and maintenance of insomnia. Despite that, little consideration is given to the role of attention. A better understanding of these mechanisms could aid the management of sleep reactivity by promoting attentional shifting strategies to divert focus from stressors and sleep.

In order to, investigate this relationship this project aims to manipulate sleep reactivity to assess the differences between insomniacs and healthy controls, taking into account their attentional shifting performance and focusing on non-REM and REM sleep alterations.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luigi Ferini Strambi, MD; Phone Number: +390226433363; Email: ferinistrambi.luigi@hsr.it
• Study Contact Backup: Name: Luigi Ferini-Strambi, MD; Phone Number: +39 +390226433363; Email: ferinistrambi.luigi@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20127
    • IRCCS Ospedale San Raffaele
    • Contact: Luigi Ferini Strambi, MD; Phone Number: 0226433363; Email: ferinistrambi.luigi@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects, both male and female
• aged over 18 and under 65;
• Ability to understand and sign the informed consent

Exclusion Criteria:

• Subjects unable to read, understand, or correctly complete the procedures required by the study
• Subjects suffering from diagnosticated sleep disorders;
• Subjects suffering from substance addiction;
• Subjects who exceed the clinical cut-off for anxiety and/or depression symptoms;
• Subjects suffering from severe or degenerative neurological diseases;
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy subjects not presenting insomnia symptoms; Group of healthy subjects not presenting insomnia symptoms (SCI>16)	Behavioral: trauma film paradigm; Use the trauma films as stressors to induce stress and evaluate how it affects sleep reactivity in healthy subjects with insomnia symptoms compared to healthy subjects without insomnia symptoms; Other Names: no other intervention
Experimental: Group of healthy subjects presenting insomnia symptoms; Group of healthy subjects presenting insomnia symptoms (SCI≤16)	Behavioral: trauma film paradigm; Use the trauma films as stressors to induce stress and evaluate how it affects sleep reactivity in healthy subjects with insomnia symptoms compared to healthy subjects without insomnia symptoms; Other Names: no other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Diary	Participants will complete a daily Sleep Diary for 18 days, recording information each morning within 10 minutes of waking. This diary will provide data on participants' subjective sleep quality, including indicators such as perceived Sleep Efficiency (pecentual), number of awakenings, sleep latency duration (minute). These metrics will allow us to detect any changes in sleep patterns following stress induction compared to the baseline period.	From enrollment tothe end of study at 18 days
Polysomnographic Recording	Using the portable Sleep Profiler device, we will capture objective data on participants' sleep in their home environment, ensuring an ecologically valid setting. This data will facilitate a comparison between two nights before and two nights after the stress intervention, examining changes in both overall sleep structure and quality and in-depth aspects of the REM phase. Outcomes will include: total sleep time (minutes), sleep onset latency (minutes), number of awakenings, wake after sleep onset (minutes), number of cortical arousals, percentage of specific sleep stages (stage 1, stage 2, slow wave sleep, REM sleep), number of arousal from REM sleep, EEG power, density of sleep spindles (raw number divided by the total minutes of stage 2).	From enrollment to 4 days
Neuropsychological Attention Assessment	This assessment will include the Attention Network Test (ANT), which evaluates the three main sub-functions of attention-alerting, orienting/shifting, and executive control. Additionally, participants will complete the Stroop Task and the Go/No-Go Task to assess inhibitory control. These results will help us determine whether certain components of attention may mediate the sleep response to stress. Reaction times and accuracy for both tasks will be considered primary outcomes.	From enrollment to 4 days

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: in submission to CETLombardia1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No