The Impact of Attentive System on Sleep Reactivity
ConditionInsomnia Due to Anxiety and Fear
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects, both male and female
aged over 18 and under 65;
Ability to understand and sign the informed consent
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
trauma film paradigm
BehavioralUse 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: healthy subjects not presenting insomnia symptomsActive comparator 1 intervention
Group B: Group of healthy subjects presenting insomnia symptomsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment tothe end of study at 18 days2
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).
Time frame
From enrollment to 4 days3
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.
Time frame
From enrollment to 4 daysSponsors and contacts
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Source ClinicalTrials.gov
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