NCT06457945

Brief Summary

Mind wandering is a state in which attention turns away from the external environment or current task to focus on internal thoughts (past experiences, future events, planned actions...). Humans are thought to spend at least one third of their waking lives in this state. Mind wandering can be assessed experimentally by investigating mental content during well-controlled tasks. In this case, task-unrelated thoughts likely to arise during tasks of varying cognitive demand are studied. Mind wandering (=task-unrelated thoughts) has a deleterious effect on cognitive performance in most paradigms, particularly those requiring sustained attention and executive control. However, this phenomenon could also have cognitive benefits, although knowledge on this issue remains limited. For example, it has been suggested that mind wandering could promote creativity, anticipation of future scenarios and prospective memory. In a recent behavioural study, we investigated the cost and benefit of mind wandering in an implicit visual-motor probabilistic learning task (ASRT - Alternating Serial Reaction Time Task). ASRT distinguishes between two fundamental processes: visuomotor performance and implicit statistical learning. While the former reflects visuo-spatial discrimination efficiency, the latter refers to the unintentional acquisition of probabilistic regularities of external inputs. Reduced visuo-spatial accuracy and faster but less accurate responses have been observed during periods of mind-wandering. On the other hand, mind-wandering was associated with enhanced statistical learning reflecting improved predictive processing. Whereas the study of the neural correlates of mind-wandering is constantly growing, the mechanisms triggering mind-wandering are far from being unravelled, but may involve sleep pressure. Thus, the frequency of mind wandering tends to increase after sleep deprivation or during attention-demanding cognitive tasks, during which neurophysiological markers of local sleep appear. These markers of sleep during wakefulness are frequently observed in hypersomnolence disorders. They are generally defined by the appearance of slow waves (typical of slow wave sleep, SWS). Nevertheless, sleep intrusions during wakefulness may not be limited to non-rapid-eye-movement (NREM) sleep but also concern REM sleep. REM sleep is the sleep state when the most intense forms of dreaming occur, and could therefore be phenomenologically similar to the reverie of mind wandering. Thus, daytime mental wandering could be triggered by intrusions of REM sleep during wakefulness. Patients with narcolepsy type 1 (NT1) exhibit frequent REM sleep onset during daytime wakefulness. The study of ASRT in this population therefore offers a unique opportunity to investigate the role of REM sleep intrusions in mind wandering. The hypothesis is that mind wandering would be observed more frequently during the ASRT task in NT1 patients (with REM sleep intrusions during wakefulness) than in patients with idiopathic hypersomnia (IH) (with NREM sleep intrusions during wakefulness) and patients with subjective hypersomnolence (little or no sleep intrusion). Furthermore, it could be possible that REM sleep-related mind wandering would be associated with impaired visuomotor performance in terms of accuracy, but improved predictive processing (probabilistic learning) compared to NREM sleep intrusions or no sleep intrusion during the task.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

May 31, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2026

Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

May 31, 2024

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference in accuracy in responses between high-and low- probability trials during the ASRT

    Statistical learning will be assessed by the difference in accuracy (percentage of correct location) in responses between high-and low probability trials during the ASRT in the 3 groups (NT1, IH, subjective sleepiness). Mean accuracy scores will be computed for each block for high-and low- probability trials, and the above learning indices will be extracted for each block.

    At inclusion, during the ASRT

  • Difference in reaction time in responses between high-and low- probability trials during the ASRT

    Statistical learning will be assessed by the difference in reaction time (in ms) in responses between high-and low probability trials during the ASRT in the 3 groups (NT1, IH, subjective sleepiness). Median reaction times will be computed for each block for high-and low- probability trials, and the above learning indices will be extracted for each block.

    At inclusion, during the ASRT

Secondary Outcomes (7)

  • Subjective states of mind during the ASRT

    At inclusion, at the end of each block of ASRT

  • Neurophysiological patterns during the ASRT

    At inclusion, during the ASRT

  • Spontaneous and Deliberate Mind Wandering Scales (SDMWS) score

    At inclusion

  • Epworth Sleepiness Scale score

    At inclusion

  • Dream recall frequency

    At inclusion

  • +2 more secondary outcomes

Study Arms (3)

Narcolepsy type 1

EXPERIMENTAL

Patients with narcolepsy type 1 according to International Classification of Sleep Disorders (ICSD3-TR) criteria; they will have to fill study questionnaires and perform the ASRT. A subset of patients will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT.

Behavioral: ASRTBehavioral: QuestionnairesDevice: Electrophysiological recordings

Idiopathic hypersomnia

EXPERIMENTAL

Patients with Idiopathic hypersomnia according to ICSD3-TR and with mean sleep latency ≤8min at the multiple sleep latency test (MSLT) (whatever total sleep time/24h bedrest); they will have to fill study questionnaires and perform the ASRT. A subset of patients will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT.

Behavioral: ASRTBehavioral: QuestionnairesDevice: Electrophysiological recordings

Subjective hypersomnolence

ACTIVE COMPARATOR

Patient with subjective hypersomnolence without underlying cause (negative extensive work-up including actigraphy, polysomnography (PSG), MSLT, 24h bedrest, biological tests, MRI, psychiatric consultation; this allows to rule out sleep deprivation, irregular sleep/wake schedule, sleep apnea or other sleep disorders associated with sleep fragmentation, somatic/psychiatric causes of hypersomnolence, sedative substance intake). A subset of patients will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT. They will have to fill study questionnaires and perform the ASRT.

Behavioral: ASRTBehavioral: QuestionnairesDevice: Electrophysiological recordings

Interventions

ASRTBEHAVIORAL

The task involves the presentation of a visual stimulus in one of four horizontal locations on the screen, and participants are instructed to indicate the location of the target stimulus by pressing the corresponding key on the keyboard. In case of correct response, the target stimulus disappears, and after a 120 ms interstimulus interval, the next stimulus appears. In case of an incorrect response, the target stimulus remains in place until the first correct response. The stimuli follow a probabilistic eight-element sequence, with pattern and random elements alternating with each other. Each participant will be assigned to one of 24 possible sequences throughout the task. The ASRT task will be composed of 25 blocks, with each block containing ten repetitions of the eight-element sequence. After each block, participants will have to take a short break and answer the thought probes before continuing. All patients will perform the task one time.

Idiopathic hypersomniaNarcolepsy type 1Subjective hypersomnolence
QuestionnairesBEHAVIORAL

All patients will have to fill questionnaire at the beginning of the study * Spontaneous and Deliberate Mind Wandering Scales (SDMWS) * Epworth Sleepiness Scale * Narcolepsy Severity Index * Idiopathic Hypersomnia Severity Scale * Hospital Anxiety and Depression scale * Horne \& Ostberg questionnaire * Attention Deficit Hyperactivity Disorder (ADHD) auto-evaluation * Pittsburgh Sleep Quality Index * Insomnia Severity Index * Psychotic-like experiences scale

Idiopathic hypersomniaNarcolepsy type 1Subjective hypersomnolence

A subset of patients in each arm will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT

Idiopathic hypersomniaNarcolepsy type 1Subjective hypersomnolence

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with NT1 or IH diagnosis according to ICSD3-TR criteria (American Academy of Sleep, 2023)
  • For patient with IH: with abnormal Mean Sleep Latency Test (MSLT) (mean latency ≤ 8 min, ≤ 1 SOREMp)
  • Patients with subjective hypersomnolence without underlying cause (negative extensive work-up including actigraphy, PSG, MSLT, 24h bedrest, biological tests, MRI, psychiatric consultation; this allows to rule out sleep deprivation, irregular sleep/wake schedule, sleep apnea or other sleep disorders associated with sleep fragmentation, somatic/psychiatric causes of hypersomnolence, sedative substance intake). This type of "controls" have already been used in studies on hypersomnolence disorders.

You may not qualify if:

  • Cognitive impairment not compatible with the task
  • Treatment with antidepressant
  • Other cause of hypersomnolence: untreated severe obstructive sleep apnea, sleep-wake circadian rhythm disorders, sleep deprivation, somatic/psychiatric causes of hypersomnolence, sedative substance intake
  • Unstable medical or psychiatric condition
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix-Rousse

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive SomnolenceIdiopathic Hypersomnia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Laure PETER-DEREX, Professor

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure PETER-DEREX, Professor

CONTACT

Dezső NEMETH, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 13, 2024

Study Start

December 3, 2024

Primary Completion (Estimated)

December 3, 2026

Study Completion (Estimated)

December 3, 2026

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations