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Self-awakening: Ability to Wake Up Without the Aid of Any TimekeeperSASNCT06685380

Cognitive Control During Sleep: the Strange Case of Self-Awakening

An observational study of Self-awakening: Ability to Wake Up Without the Aid of Any Timekeeper, run by IRCCS San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Not applicable- observational study
How many people
40 participants
Where
1 siteItaly
Study dates
22 Jan 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: IRCCS Ospedale San Raffaele UO Neurologia - Centro di Medicina del Sonno Via Stamira D'Ancona, 20 20127 Milano, Italy

Who may be able to join

  • Subjects, both men and women
  • 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 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luigi Ferini-Strambi, MD contact

+390226433363

ferinistrambi.luigi@hsr.it

Italy1 site, 1 recruiting
  • UO Neurologia Centro di Medicina del sonno

    Milan, Italy, 20127

    Luigi Ferini-Strambi, MD, +390226433363, ferinistrambi.luigi@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: Cognitive Control During Sleep: the Strange Case of Self-Awakening, a Prospective Observational Study

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.

Read the detailed description

Sleep is often mistakenly conceived as a passive state; however, it actually plays a fundamental role in regulating daytime cognitive functions such as memory and emotion (Klinzing et al., 2019). Additionally, other phenomena suggest that complex cognitive processing may be active during sleep. For example, lucid dreaming, the ability to be aware of dreaming while in the dream, involves a form of volitional control during sleep (Baird et al., 2019). Another scarcely studied experience related to regained cognitive activity during sleep is self-awakening. People habitually use alarms to wake up at a specific time in the morning. Interestingly, some individuals report the ability to wake up without the aid of any timekeeper; we refer to this phenomenon as self-awakening. Although the experience is commonly reported, certain specifics are needed to identify and understand the phenomenon.

Firstly, awakening from sleep can be induced by external stimuli but may also occur spontaneously. Secondly, spontaneous awakening can be divided into natural awakening, caused by a "natural" cessation of sleep due to the dissipation of physiological sleep pressure, or self-awakening, driven by the intent to wake up. Thirdly, self-awakening itself requires clarification: it may be habitual (i.e., a person wakes up at the same time every day), in which case circadian rhythms are the driving factor, or it can be induced by will. This latter phenomenon is the primary focus of interest here.

Studying self-awakening is not only fascinating but could also provide insights into the presence of specific cognitive processes even at minimal or absent levels of consciousness. There are at least three cognitive operations that a sleeping person must successfully perform to awaken at the intended time. First, they must encode and remember the target time, which should be easily accessible; second, elapsed time during sleep should be constantly estimated and compared to the target time; third, one must regain voluntary control during sleep to awaken. All these operations must be carried out while the sleeping subject is in a state typically characterized by minimal levels of consciousness (Tononi \& Massimini, 2008).

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.

Being tested
Not applicable- observational study
Keywords
self-awakening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not applicable- observational studyOther

    For observational studies, participants are not assigned an intervention as part of the study

Study groups in NCT06685380
Study groupRoleWhat they receive
Self AwakeningNot described
Receives: Other: Not applicable- observational study
ControlNot described
Receives: Other: Not applicable- observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcomes will involve actigraphic evaluation

    • Actigraphic assessment will be conducted over two weeks, during which subjects will be asked to perform self-awakenings in the second week of recording. The actual number of self-awakenings will then be calculated based on the requested self-awakenings, as well as accuracy, defined as the discrepancy in minutes between the target wake-up time and the actual wake-up time.

    Measured: From enrollment to the end of assessment at 2 weeks

  2. Primary outcomes will involve polysomnographic evaluation

    Polysomnographic recording will be employed to assess neurophysiological brain dynamics under conditions of forced awakening and during a night with self-awakening, along with a neuropsychological approach to assess cognitive control and time estimation abilities. The reduction in the density and power of slow waves in the 30 minutes prior to awakening in the two different conditions will be calculated.

    Measured: From enrollment to the end of assessment at 2 weeks

  3. Primary outcomes will involve neuropsychological evaluation

    Neuropsychological assessment will include the flanker task, measuring accuracy and reaction times under various cognitive control conditions, and an interval reproduction task, evaluating accuracy and errors

    Measured: From enrollment to the end of assessment at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start22 Jan 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685380
Sponsor's protocol ID
CET 68-2023
Acronym
SAS
Status last verified
Nov 2024
First submitted
6 Nov 2024
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Self-awakening: Ability to Wake Up Without the Aid of Any Timekeeper, 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luigi Ferini-Strambi, MD (+390226433363, ferinistrambi.luigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcomes will involve actigraphic evaluation (time frame: From enrollment to the end of assessment at 2 weeks). The study lists 3 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 15 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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