The Impact of Attentive System on Sleep Reactivity

NCT06694818 | Not Yet Recruiting DMC

• 1 other identifier: in submission to CETLombardia1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia Due to Anxiety and Fear

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

healthy subjects not presenting insomnia symptoms

ACTIVE COMPARATOR

Group of healthy subjects not presenting insomnia symptoms (SCI\>16)

Behavioral: trauma film paradigm

Group of healthy subjects presenting insomnia symptoms

EXPERIMENTAL

Group of healthy subjects presenting insomnia symptoms (SCI≤16)

Behavioral: trauma film paradigm

Interventions

trauma film paradigm BEHAVIORAL

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

Also known as: no other intervention

Group of healthy subjects presenting insomnia symptoms; healthy subjects not presenting insomnia symptoms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale san Raffaele

Milan, Italy, 20127, Italy

Location

Central Study Contacts

Luigi Ferini Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Luigi Ferini-Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)