Narcolepsy Type 1NARCOWANDERINGNCT06457945
Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions
A study testing ASRT, Questionnaires and Electrophysiological recordings in people with Narcolepsy Type 1 and Hypersomnolence, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy Type 1, Hypersomnolence, Idiopathic Hypersomnia
- What is being tested?
- ASRT, Questionnaires and Electrophysiological recordings
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2024to 3 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dezső NEMETH, PhD contact
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix-Rousse
Lyon, 69004
Laure PETER-DEREX, Professor, +33 (0)4 72 07 28 08, laure.peter-derex@chu-lyon.fr
Laure PETER-DEREX, Professor
About this study
Official title: Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions, the NarcoWandering Study
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.
- Conditions
- Narcolepsy Type 1, Hypersomnolence, Idiopathic Hypersomnia
- Being tested
- ASRT, Questionnaires, Electrophysiological recordings
- Medical subject headings
- Disorders of Excessive Somnolence, Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASRTBehavioural
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.
QuestionnairesBehavioural
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
Electrophysiological recordingsDevice
A subset of patients in each arm will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ASRT; Behavioral: Questionnaires; Device: 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. Receives: Behavioral: ASRT; Behavioral: Questionnaires; Device: 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. Receives: Behavioral: ASRT; Behavioral: Questionnaires; Device: Electrophysiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At inclusion, during the ASRT
Secondary outcomes (7)
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)
Measured: 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)
Measured: At inclusion, during the ASRT
Spontaneous and Deliberate Mind Wandering Scales (SDMWS) score
Measured: At inclusion
Epworth Sleepiness Scale score
Subjective sleepiness will be assessed thnaks to Epworth Sleepiness Scale
Measured: At inclusion
Dream recall frequency
Dream recall frequency (n/week, diary the week before the ASRT)
Measured: At inclusion
Frequency of sleep-related hallucinations
Frequency of sleep-related hallucinations (nb/week, item of the Narcolepsy Severity Scale)
Measured: At inclusion
Insomnia Severity Index score
Nighttime sleep quality assessed thanks to the Insomnia Severity Index.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start3 Dec 2024
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure PETER-DEREX, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457945
- Sponsor's protocol ID
- 69HCL24_0179
- Acronym
- NARCOWANDERING
- Status last verified
- Jan 2025
- First submitted
- 31 May 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions, the NarcoWandering Study
- ClinicalTrials.gov ID
- NCT06457945
- Acronym / sponsor ID
- NARCOWANDERING / 69HCL24_0179
- Conditions
- Narcolepsy Type 1, Hypersomnolence, Idiopathic Hypersomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy type 1 | Experimental | Behavioral: ASRT, Behavioral: Questionnaires, Device: Electrophysiological recordingsPatients 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. |
| Idiopathic hypersomnia | Experimental | Behavioral: ASRT, Behavioral: Questionnaires, Device: Electrophysiological recordingsPatients 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. |
| Subjective hypersomnolence | Active comparator | Behavioral: ASRT, Behavioral: Questionnaires, Device: Electrophysiological recordingsPatient 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASRTThe 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. | Behavioural | Idiopathic hypersomnia, Narcolepsy type 1, Subjective hypersomnolence |
| QuestionnairesAll 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 | Behavioural | Idiopathic hypersomnia, Narcolepsy type 1, Subjective hypersomnolence |
| Electrophysiological recordingsA subset of patients in each arm will undergo polysomnography recording (EEG, EOG, EMG, ECG) during the ASRT | Device | Idiopathic hypersomnia, Narcolepsy type 1, Subjective hypersomnolence |
Primary outcome
Difference in accuracy in responses between high-and low- probability trials during the ASRT
Time frame: At inclusion, 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.
Difference in reaction time in responses between high-and low- probability trials during the ASRT
Time frame: At inclusion, 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.
7 secondary outcomes
Subjective states of mind during the ASRT
Time frame: At inclusion, at the end of each block of ASRT
Neurophysiological patterns during the ASRT
Time frame: At inclusion, during the ASRT
Spontaneous and Deliberate Mind Wandering Scales (SDMWS) score
Time frame: At inclusion
Epworth Sleepiness Scale score
Time frame: At inclusion
Dream recall frequency
Time frame: At inclusion
Frequency of sleep-related hallucinations
Time frame: At inclusion
Insomnia Severity Index score
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dezső NEMETH, PhD contact
Laure PETER-DEREX, Professor principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASRT, Questionnaires and Electrophysiological recordings in people with Narcolepsy Type 1 and Hypersomnolence, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 13 Jan 2025. 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 France. 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 Laure PETER-DEREX, Professor (+33 04 72 07 19 29, laure.peter-derex@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in accuracy in responses between high-and low- probability trials during the ASRT (time frame: At inclusion, during the ASRT). The study lists 2 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 13 Jan 2025.