NCT06685380 Cognitive Control During Sleep: the Strange Case of Self-Awakening
| NCT ID | NCT06685380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Self-awakening: Ability to Wake Up Without the Aid of Any Timekeeper |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-01-22 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The experimental model of self-awakening highlights several important issues, particularly the lack of a reliable model for estimating the time interval, from minutes to hours, that passes between falling asleep at night and the moment of self-awakening. This may be explained by limited knowledge of ultradian brain oscillators (i.e., biorhythms with periods shorter than 24 hours) related to the perception of time during nighttime sleep, although the processes involved in the internal timing of circadian rhythms have been extensively studied. These are biologically regulated by a relatively small group of around 10,000 neurons in the suprachiasmatic nucleus of the hypothalamus, oscillating with a 24-hour rhythm. Little is known about ultradian timekeepers of sleep, especially related to the REM (Rapid Eye Movement) sleep cycle, but they likely play a crucial role in self-awakening. So far, self-awakening has been studied using various subjective and objective methodologies, including questionnaires, sleep diaries, actigraphy, and polysomnography. However, no study has integrated all these different approaches Objective The primary aim of this project will be to investigate the psychophysiological and neuropsychophysiological characteristics underlying the phenomenon of self-awakening, introducing an innovative multimodal approach by combining three main methodologies (ecological assessment, neuropsychological approach, and polysomnographic recording). Specifically, the first part of the study will aim to confirm, through an actigraphic survey, that subjects who report this ability at a subjective level (evaluated via the SAQ questionnaire) are indeed capable of performing it. Secondly, the polysomnographic study will aim to evaluate the EEG characteristics of 'self-awakeners' in the 30 minutes preceding self-awakening, compared to those preceding forced awakening caused by an external stimulus. Finally, the neuropsychological assessment will aim to evaluate differences in the cognitive control domains and temporal estimation abilities in 'self-awakeners' compared to subjects unable to self-awaken. The hypothesis is that subjects capable of self-awakening will exhibit distinctive neurophysiological and neuropsychological characteristics. In particular, these subjects are expected to show a reduction in the density and power of slow waves starting 30 minutes before self-awakening, thus indicating the ability to inhibit deep sleep in preparation for wakefulness. Additionally, it is hypothesized that these subjects may exhibit better performance in neuropsychological variables related to cognitive control and temporal estimation.
Eligibility Criteria
Inclusion Criteria: * Subjects, both men and women * 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 with significant respiratory disorders (respiratory failure, pneumopathy, pneumothorax, COPD-Chronic Obstructive Pulmonary Disease) and sleep-related respiratory disorders (OSA-Obstructive Sleep Apnea Syndrome, central apneas) * Subjects with nocturnal epilepsy, epilepsy, REM (Rapid Eye Movement) and NREM (Non-Rapid Eye Movement) parasomnias * Subjects with neurological and/or psychiatric disorders * Subjects with any form of senile dementia * Subjects with significant internal medical conditions that could impair sleep, at the discretion of the study physician (diabetes, arterial hypertension, thyroid disorders, metabolic syndrome)
Contact & Investigator
Luigi Ferini-Strambi, MD
PRINCIPAL INVESTIGATOR
UO Neurologia Centro di Medicina del sonno
Frequently Asked Questions
Who can join the NCT06685380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Self-awakening: Ability to Wake Up Without the Aid of Any Timekeeper. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06685380 currently recruiting?
Yes, NCT06685380 is actively recruiting participants. Contact the research team at ferinistrambi.luigi@hsr.it for enrollment information.
Where is the NCT06685380 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06685380 clinical trial?
NCT06685380 is sponsored by IRCCS San Raffaele. The principal investigator is Luigi Ferini-Strambi, MD at UO Neurologia Centro di Medicina del sonno. The trial plans to enroll 40 participants.