Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06457945
Other study ID # 69HCL24_0179
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date June 15, 2026

Study information

Verified date May 2024
Source Hospices Civils de Lyon
Contact Laure PETER-DEREX, Professor
Phone +33 04 72 07 19 29
Email laure.peter-derex@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date June 15, 2026
Est. primary completion date June 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ASRT
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.
Questionnaires
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
Device:
Electrophysiological recordings
A subset of patients in each arm will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT

Locations

Country Name City State
France Hôpital de la Croix-Rousse Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Subjective states of mind during the ASRT Distribution of subjective states of mind (mind wandering, mind blanking, focus on task) assessed at the end of each block during the ASRT in the 3 groups (NT1, IH, subjective sleepiness) At inclusion, at the end of each block of ASRT
Secondary Neurophysiological patterns during the ASRT Neurophysiological patterns (EEG, electro-oculography (EOG), electromyography (EMG), ECG to detect sleep intrusion: micro-REM and micro-NREM) will be assessed for each block during the ASRT in all patients and each group of patient (NT1, IH and subjective hypersomnolence) EEG features: spectral power (aperiodic and periodic components, relative and theta-delta/alpha-beta ratio vs pre-task baseline) and specific grapho-elements such as sawtooth waves, alpha bursts and beta oscillations; 2) EMG: muscle tone (% vs pre-task baseline), 3) EOG: presence and % slow vs rapid vs no eye movements, 4) ECG: heart rate, heart rate variability (SDNN, RMSSD), heartbeat evoked potentials) At inclusion, during the ASRT
Secondary Spontaneous and Deliberate Mind Wandering Scales (SDMWS) score At inclusion
Secondary Epworth Sleepiness Scale score Subjective sleepiness will be assessed thnaks to Epworth Sleepiness Scale At inclusion
Secondary Dream recall frequency Dream recall frequency (n/week, diary the week before the ASRT) At inclusion
Secondary Frequency of sleep-related hallucinations Frequency of sleep-related hallucinations (nb/week, item of the Narcolepsy Severity Scale) At inclusion
Secondary Insomnia Severity Index score Nighttime sleep quality assessed thanks to the Insomnia Severity Index. At inclusion
See also
  Status Clinical Trial Phase
Recruiting NCT04026958 - Clarithromycin Mechanisms in Hypersomnia Syndromes Phase 2
Completed NCT02512588 - A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2 Phase 2
Completed NCT01183312 - Flumazenil for the Treatment of Primary Hypersomnia Phase 1/Phase 2
Completed NCT03597555 - Sodium Oxybate in Idiopathic Hypersomnia Phase 2/Phase 3
Completed NCT03356938 - The Role of the Circadian System in Neurological Sleep-wake Disorders N/A
Completed NCT03533114 - A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension Phase 3
Active, not recruiting NCT03542851 - A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia Phase 2
Completed NCT05156047 - A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia Phase 3
Enrolling by invitation NCT05371483 - Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments
Not yet recruiting NCT06252571 - a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial Phase 2
Completed NCT04827329 - Anesthetic Management of Patients With Chronic Sleep Disorders
Recruiting NCT05875974 - Ph4 PSG Combined JZP258-407 Phase 4
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT01146600 - Clarithromycin for the Treatment of Hypersomnia Phase 2
Recruiting NCT04330963 - International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Completed NCT04091438 - A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia Phase 1
Recruiting NCT05615584 - Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence N/A
Recruiting NCT05837091 - Low Sodium Oxybate in Patients With Idiopathic Hypersomnia Phase 4
Recruiting NCT05321355 - Mainz Register of Patients With Sleep Disorders
Active, not recruiting NCT05668754 - Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH Phase 2