Insomnia Due to Anxiety and FearSREEGNCT06694818
The Impact of Attentive System on Sleep Reactivity
A study testing trauma film paradigm in people with Insomnia Due to Anxiety and Fear, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Due to Anxiety and Fear
- What is being tested?
- trauma film paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects, both male and female
- aged over 18 and under 65;
- Ability to understand and sign the informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia Due to Anxiety and Fear
- Being tested
- trauma film paradigm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trauma film paradigmBehavioural
Also called no other intervention
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
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects not presenting insomnia symptoms | Active comparator | Group of healthy subjects not presenting insomnia symptoms (SCI>16) Receives: Behavioral: trauma film paradigm |
| Group of healthy subjects presenting insomnia symptoms | Experimental | Group of healthy subjects presenting insomnia symptoms (SCI≤16) Receives: Behavioral: trauma film paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency (%)_PSG recording
Using the portable Sleep Profiler device, the investigators will capture data on participants' sleep in their home environment, ensuring an ecologically valid setting. sleep efficiency is expressed in % reporting the ratio between time in bed and total sleep time (range 0-100).
Measured: From enrollment to 4 days
Sleep Diary_Sleep efficiency (%)
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).Sleep efficiency is expressed in % reporting the ratio between time in bed and total sleep time (range 0-100).
Measured: From enrollment tothe end of study at 18 days
Neuropsychological Attention Assessment_Reaction time (ms)
The Attention Network Test (ANT), which evaluates reaction times (millisec) related to executive functions.
Measured: From enrollment to 4 days
Polysomnographic Recording_REM Phase (%)
Using the portable Sleep Profiler device, the investigators will capture data on participants' sleep in their home environment, ensuring an ecologically valid setting. REM % is expressed as ratio between toital sleep time and times spent during REM sleep period.
Measured: From enrollment to 4 days
Secondary outcomes (1)
Neuropsychological Attention Assessment_stroop reaction time (ms)
The Stroop Task evaluates the reaction time in millisec.
Measured: From enrollment to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Jan 2025
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Anxiety and FearStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Ferini Strambi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694818
- Sponsor's protocol ID
- CETLombardia1
- Acronym
- SREEG
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Attentive System on Sleep Reactivity: a Study With a Participant-applied Electroencephalography in the Home Environment
- ClinicalTrials.gov ID
- NCT06694818
- Acronym / sponsor ID
- SREEG / CETLombardia1
- Conditions
- Insomnia Due to Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects not presenting insomnia symptoms | Active comparator | Behavioral: trauma film paradigmGroup of healthy subjects not presenting insomnia symptoms (SCI>16) |
| Group of healthy subjects presenting insomnia symptoms | Experimental | Behavioral: trauma film paradigmGroup of healthy subjects presenting insomnia symptoms (SCI≤16) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects, both male and female
- aged over 18 and under 65;
- Ability to understand and sign the informed consent
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trauma film paradigmAlso: no other interventionUse 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 | Behavioural | Group of healthy subjects presenting insomnia symptoms, healthy subjects not presenting insomnia symptoms |
Primary outcome
Sleep Efficiency (%)_PSG recording
Time frame: From enrollment to 4 days
Using the portable Sleep Profiler device, the investigators will capture data on participants' sleep in their home environment, ensuring an ecologically valid setting. sleep efficiency is expressed in % reporting the ratio between time in bed and total sleep time (range 0-100).
Sleep Diary_Sleep efficiency (%)
Time frame: From enrollment tothe end of study at 18 days
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).Sleep efficiency is expressed in % reporting the ratio between time in bed and total sleep time (range 0-100).
Neuropsychological Attention Assessment_Reaction time (ms)
Time frame: From enrollment to 4 days
The Attention Network Test (ANT), which evaluates reaction times (millisec) related to executive functions.
Polysomnographic Recording_REM Phase (%)
Time frame: From enrollment to 4 days
Using the portable Sleep Profiler device, the investigators will capture data on participants' sleep in their home environment, ensuring an ecologically valid setting. REM % is expressed as ratio between toital sleep time and times spent during REM sleep period.
1 secondary outcome
Neuropsychological Attention Assessment_stroop reaction time (ms)
Time frame: From enrollment to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trauma film paradigm in people with Insomnia Due to Anxiety and Fear, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (%)_PSG recording (time frame: From enrollment to 4 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.