An interventional study of ASRT and Questionnaires in Narcolepsy Type 1, Hypersomnolence and Idiopathic Hypersomnia, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
Among 17 studies in Idiopathic Hypersomnia with a site in France — 9 open to participants now, 10 under way, 1 of them phase 3. Idiopathic Hypersomnia · France.
Among the 17 studies in Idiopathic Hypersomnia with a site in France, this one is the 4th largest by planned enrollment of the 13 interventional ones, is one of 6 that started in 2024, is one of 5 with no phase, and was the 10th registered.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 180 is above the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →9 of the 17 studies in Idiopathic Hypersomnia with a site in France are open now, in 11 countries. Each count lists the studies.
Of the 17 Idiopathic Hypersomnia studies recruiting now, 4 (24%) set no upper age limit and 12 (71%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 6 started in 2024.
Median enrollment 117 across the 13 interventional studies, 72 across the 4 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
5 of 17 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 2 studies filed under Idiopathic Hypersomnia — fewer than ten, so there is no comparison to draw.
7 of the studies in Idiopathic Hypersomnia with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06590662University Hospital, MontpellierEfficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. | 2026-11-15 |
| NCT06812078TakedaA Study of TAK-360 in Adults With Idiopathic Hypersomnia | 2026-11-30 |
| NCT06752668Centessa Pharmaceuticals (UK) LimitedA Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia | 2026-12 |
| NCT06457945Hospices Civils de LyonMind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions | 2026-12-03 |
Among the 17 studies in Idiopathic Hypersomnia with a site in France, from their registry updates:
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.
52 studies on the registry are indexed under Idiopathic Hypersomnia; 23 are open to participants now.
This study's planned enrollment of 180 is above the median of 82 across 40 interventional studies indexed under Idiopathic Hypersomnia.
Browse Idiopathic Hypersomnia studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Compared within Idiopathic Hypersomnia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disorders of Excessive Somnolence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: ASRT · Behavioral: Questionnaires · Device: Electrophysiological recordings
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: ASRT · Behavioral: Questionnaires · Device: Electrophysiological recordings
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: ASRT · Behavioral: Questionnaires · Device: Electrophysiological recordings
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.
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
A subset of patients in each arm will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT
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.
Time frame: 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.
Time frame: At inclusion, during the ASRT
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)
Time frame: At inclusion, at the end of each block of ASRT
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)
Time frame: At inclusion, during the ASRT
Spontaneous and Deliberate Mind Wandering Scales (SDMWS) score
Time frame: At inclusion
Epworth Sleepiness Scale score
Subjective sleepiness will be assessed thnaks to Epworth Sleepiness Scale
Time frame: At inclusion
Dream recall frequency
Dream recall frequency (n/week, diary the week before the ASRT)
Time frame: At inclusion
Frequency of sleep-related hallucinations
Frequency of sleep-related hallucinations (nb/week, item of the Narcolepsy Severity Scale)
Time frame: At inclusion
Insomnia Severity Index score
Nighttime sleep quality assessed thanks to the Insomnia Severity Index.
Time frame: At inclusion
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.