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

NCT06685380 | Recruiting DMC

• 1 other identifier: CET 68-2023
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

self-awakening

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of assessment at 2 weeks

• 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.

  From enrollment to the end of assessment at 2 weeks

• 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

  From enrollment to the end of assessment at 2 weeks

Other Outcomes (1)

• Other relevant outcomes for the study

  From enrollment to the end of assessment at 2 weeks

Study Arms (2)

Self Awakening

Other: Not applicable- observational study

Control

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

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

Control; Self Awakening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subjects, both men and women
• 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 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)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

UO Neurologia Centro di Medicina del sonno

Milan, Italy, 20127, Italy

RECRUITING

Study Officials

• Luigi Ferini-Strambi, MD

  UO Neurologia Centro di Medicina del sonno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Ferini-Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)