NREM ParasomniasDoA-CLASNCT07754838
Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
A study testing Closed-Loop/Open-Loop Acoustic Stimulation (CLAS) in people with NREM Parasomnias and Sleepwalking, run by Anna Castelnovo at 1 site in Switzerland.
Trial summary
Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep. Researchers do not fully understand what triggers these episodes or how to influence them. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- NREM Parasomnias, Sleepwalking, Sleep Terrors
- What is being tested?
- Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 30 Jul 2030
- 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 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For participants with Disorders of Arousal (DoA):
- Diagnosis of a Disorder of Arousal (sleepwalking, sleep terror, or confusional arousal) per ICSD-3 criteria, confirmed by video-polysomnography or by clinical diagnosis plus a positive Arousal Disorders Questionnaire (ADQ) and compatible history
- Age 6-17 years (paediatric) or 18-60 years (adult) at enrollment
- At least one documented episode in the 4 weeks (paediatric) or 6 months (adult) prior to enrollment
- Ability to understand and complete study materials in Italian
- Written informed consent (and age-appropriate assent for minors, per Swiss Human Research Act Art. 22-23)
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- For healthy volunteers:
- No documented sleep disorder, confirmed by clinical interview, questionnaires, or prior instrumental examination
- Age- and sex-matched to the paediatric DoA group
- No clinically significant psychiatric or neurological history
- Written informed consent and age-appropriate assent
Who cannot join
- Epilepsy or other major neurological disorder
- Comorbid REM sleep behavior disorder or other REM parasomnia
- Current psychopharmacological or psychotropic medication (except melatonin ≤2 mg)
- Neurodevelopmental disorder precluding protocol collaboration (paediatric participants)
- Clinically relevant sleep-disordered breathing (Apnea-Hypopnea Index >5 events/hour)
- Clinically significant hearing deficit
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- Significant sleep deprivation in the 48 hours prior to laboratory recording
- Pregnancy (adult participants)
- Inadequate EEG recording quality (>40% artifact channels or epochs) - applied at the session level
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Ospedale Italiano di Lugano
Lugano, Canton Ticino, 6962
Anna Castelnovo, MD, PhD, +41 91 811 6117, anna.castelnovo@eoc.ch
About this study
Official title: Closed-Loop and Open-Loop Acoustic Stimulation During Sleep to Investigate and Modulate Disorders of Arousal in Children and Adults
Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep. Researchers do not fully understand what triggers these episodes or how to influence them.
This study tests whether playing soft sounds during sleep can help researchers learn more about, and possibly induce or modulate, these episodes under safe, supervised conditions. Participants with DoA will spend two nights in the sleep laboratory, with painless sensors placed on the scalp and body (similar to a regular sleep study). On one night, no sound is played. On the other night, soft sounds are played during deep sleep. The order of the two nights is decided randomly for each participant.
Read more
A small group of healthy volunteers without DoA will also take part, undergoing a single night with sound stimulation, to help researchers understand whether the sounds affect everyone the same way or specifically trigger episodes in people with DoA.
A subgroup of participants with DoA will also take part in a later, exploratory step in which the sound is triggered automatically, in real time, based on brain activity patterns.
The sounds used are very quiet, similar in volume to normal conversation, and stimulation is stopped right away if a participant shows any discomfort. The goal of this research is to better understand what triggers Disorders of Arousal, and to test whether sound-based stimulation could one day help study or manage this condition.
Read the detailed description
Disorders of Arousal (DoA)-including sleepwalking, sleep terrors, and confusional arousals-are NREM parasomnias whose underlying neurophysiological triggers remain poorly understood. A growing body of evidence suggests that DoA episodes do not emerge randomly from sleep but arise from identifiable pre-episode EEG states characterized by increased slow-wave activity and reduced cortical activation, consistent with a transient state of arousal instability. Closed-loop acoustic stimulation (CLAS) is an established, non-invasive method for probing and modulating NREM sleep physiology, but has not previously been applied in the specific context of NREM parasomnias.
This study investigates whether controlled acoustic stimulation, initially delivered with randomized timing and subsequently in a real-time, EEG-triggered closed-loop fashion, can reliably elicit or modulate DoA episodes under supervised laboratory conditions. A small group of healthy volunteers undergoes a single stimulation night to estimate the specificity of stimulation-elicited motor responses, helping distinguish genuine DoA vulnerability from a non-specific arousal response to sound.
The within-subject, randomized-order design in DoA participants allows each to serve as their own control, isolating the effect of acoustic stimulation from other sources of night-to-night variability. The exploratory closed-loop sub-study tests the technical feasibility of triggering stimulation based on real-time EEG markers of vulnerability, representing a first step toward future predictive or modulation-based approaches for this condition.
This study is part of a broader research programme on the neurobiological characterization of Disorders of Arousal; related observational components (including neuroimaging, neuropsychological assessment, and home monitoring) are registered separately.
- Conditions
- NREM Parasomnias, Sleepwalking, Sleep Terrors, Confusional Arousals
- Being tested
- Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)
- Keywords
- Disorders of arousal, Somnambulism, Parasomnia, Consciousness, Closed-loop acoustic stimulation, High-density EEG, Slow-wave sleep, Pediatric sleep disorders, Sleep medicine
- Medical subject headings
- Somnambulism, Night Terrors, Sleep Arousal Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)Device
Brief, low-intensity auditory stimuli (pure tones or noise bursts, 50-70 dB SPL, approximately 1 second in duration) delivered via a standard speaker during confirmed slow-wave sleep (SWS). In the initial open-loop phase, stimuli are presented with randomized timing. In a later closed-loop sub-study, stimuli are triggered automatically in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows. Stimulation is immediately interrupted in the event of distress, full awakening, or any adverse reaction.
| Study group | Role | What they receive |
|---|---|---|
| DoA - No-Stimulation Night (Baseline) | No intervention | Participants with DoA (N=55) undergo overnight high-density EEG and video-polysomnography with no acoustic stimulation. Within-subject baseline condition; order relative to Arm 2 is randomized per participant. |
| DoA - Acoustic Stimulation Night | Experimental | The same DoA participants (N=55) undergo overnight high-density EEG and video-polysomnography with low-intensity open-loop acoustic stimulation delivered during slow-wave sleep; order relative to Arm 1 is randomized per participant. A subset of 10 participants additionally undergoes a later, exploratory real-time closed-loop stimulation sub-phase. Receives: Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS) |
| Healthy Control - Single Stimulation Night | Experimental | A separate group of healthy participants (N=5) undergoes a single overnight high-density EEG and video-polysomnography recording including open-loop acoustic stimulation during slow-wave sleep, to estimate the specificity of stimulation-elicited motor responses relative to the DoA group. Receives: Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night
Number of video-polysomnographically confirmed Disorders of Arousal (DoA) episodes (sleepwalking, sleep terror, or confusional arousal), compared within-subject between the stimulation night and the no-stimulation (baseline) night.
Measured: Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks
Secondary outcomes (5)
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation Night
Mean duration (seconds) of video-polysomnographically confirmed DoA episodes, compared within-subject between the stimulation night and the no-stimulation (baseline) night.
Measured: Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks.
Proportion of Slow-Wave Sleep Epochs With Successful Stimulation Trigger (Percentage)
Percentage of detected slow-wave sleep epochs in which acoustic stimulation was successfully triggered within the predefined target window, during the stimulation night.
Measured: Assessed during the stimulation-night overnight recording, up to 6 weeks.
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation
Participant-rated discomfort attributable to acoustic stimulation, using a 0-10 visual analogue scale (0 = no discomfort, 10 = worst imaginable discomfort)
Measured: Assessed the morning following the stimulation night, up to 6 weeks.
Arousal Index (EEG Arousals per Hour of Sleep): Stimulation Night vs. No-Stimulation Night
Arousal index (number of EEG-defined arousals per hour of total sleep time, scored per AASM criteria), compared between the stimulation night and the no-stimulation night.
Measured: Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Sleep Efficiency (Percentage): Stimulation Night vs. No-Stimulation Night
Sleep efficiency (percentage of time in bed spent asleep), derived from polysomnographic sleep staging, compared between the stimulation night and the no-stimulation night.
Measured: Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NREM ParasomniasStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized crossover design. Each DoA participant undergoes two within-subject conditions on separate laboratory nights, at least 48 hours apart: a no-stimulation (baseline) night and a stimulation night (randomized low-intensity acoustic stimulation during slow-wave sleep). The order in which each participant receives the two nights is randomized. A subset of participants additionally takes part in a later, exploratory closed-loop sub-study in which acoustic stimuli are triggered in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Castelnovo
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bologna, University of Wisconsin, Madison, University of the Italian Switzerland, University of Applied Sciences and Arts of Southern Switzerland
- Responsible party
- Sponsor-investigator, Anna Castelnovo, Neurocenter of Southern Switzerland
- Investigators
- Anna Castelnovo, Principal investigator, Neurocenter of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754838
- Sponsor's protocol ID
- AMBIZIONE-DoA-CLAS-2026
- Other IDs
- PZ00-3_233285
- Acronym
- DoA-CLAS
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcome measures (high-density EEG recordings, episode classification, and questionnaire-derived measures) will be made available following publication of the primary results, in accordance with the SNSF Open Research Data policy and FAIR Data Principles ("as open as possible, as closed as necessary"). Derived and anonymized EEG datasets and analysis code will be deposited in FAIR-compliant, non-commercial repositories (e.g., OpenNeuro, Zenodo) with persistent identifiers, and released under a Creative Commons Attribution license (CC BY 4.0), unless stronger restrictions are required. Raw high-density EEG with synchronized video cannot be made openly available, as full anonymization is not feasible; these data will be deposited only in repositories supporting controlled access (e.g., EBRAINS), with access granted upon reasoned request to a Data Access Committee, subject to a Data Use Agreement and complian
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop and Open-Loop Acoustic Stimulation During Sleep to Investigate and Modulate Disorders of Arousal in Children and Adults
- ClinicalTrials.gov ID
- NCT07754838
- Acronym / sponsor ID
- DoA-CLAS / AMBIZIONE-DoA-CLAS-2026
- Conditions
- NREM Parasomnias, Sleepwalking, Sleep Terrors, Confusional Arousals
- Keywords
- Disorders of arousal, Somnambulism, Parasomnia, Consciousness, Closed-loop acoustic stimulation, High-density EEG, Slow-wave sleep, Pediatric sleep disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Anna CastelnovoUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bologna, University of Wisconsin, Madison, University of the Italian Switzerland, University of Applied Sciences and Arts of Southern Switzerland
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 10 Aug 2026 (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.
Disorders of Arousal (DoA)-such as sleepwalking, sleep terrors, and confusional arousals-are common sleep problems that happen during deep, non-dreaming sleep. Researchers do not fully understand what triggers these episodes or how to influence them.
This study tests whether playing soft sounds during sleep can help researchers learn more about, and possibly induce or modulate, these episodes under safe, supervised conditions. Participants with DoA will spend two nights in the sleep laboratory, with painless sensors placed on the scalp and body (similar to a regular sleep study). On one night, no sound is played. On the other night, soft sounds are played during deep sleep. The order of the two nights is decided randomly for each participant.
A small group of healthy volunteers without DoA will also take part, undergoing a single night with sound stimulation, to help researchers understand whether the sounds affect everyone the same way or specifically trigger episodes in people with DoA.
A subgroup of participants with DoA will also take part in a later, exploratory step in which the sound is triggered automatically, in real time, based on brain activity patterns.
The sounds used are very quiet, similar in volume to normal conversation, and stimulation is stopped right away if a participant shows any discomfort. The goal of this research is to better understand what triggers Disorders of Arousal, and to test whether sound-based stimulation could one day help study or manage this condition.
Detailed description
Disorders of Arousal (DoA)-including sleepwalking, sleep terrors, and confusional arousals-are NREM parasomnias whose underlying neurophysiological triggers remain poorly understood. A growing body of evidence suggests that DoA episodes do not emerge randomly from sleep but arise from identifiable pre-episode EEG states characterized by increased slow-wave activity and reduced cortical activation, consistent with a transient state of arousal instability. Closed-loop acoustic stimulation (CLAS) is an established, non-invasive method for probing and modulating NREM sleep physiology, but has not previously been applied in the specific context of NREM parasomnias.
This study investigates whether controlled acoustic stimulation, initially delivered with randomized timing and subsequently in a real-time, EEG-triggered closed-loop fashion, can reliably elicit or modulate DoA episodes under supervised laboratory conditions. A small group of healthy volunteers undergoes a single stimulation night to estimate the specificity of stimulation-elicited motor responses, helping distinguish genuine DoA vulnerability from a non-specific arousal response to sound.
The within-subject, randomized-order design in DoA participants allows each to serve as their own control, isolating the effect of acoustic stimulation from other sources of night-to-night variability. The exploratory closed-loop sub-study tests the technical feasibility of triggering stimulation based on real-time EEG markers of vulnerability, representing a first step toward future predictive or modulation-based approaches for this condition.
This study is part of a broader research programme on the neurobiological characterization of Disorders of Arousal; related observational components (including neuroimaging, neuropsychological assessment, and home monitoring) are registered separately.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized crossover design. Each DoA participant undergoes two within-subject conditions on separate laboratory nights, at least 48 hours apart: a no-stimulation (baseline) night and a stimulation night (randomized low-intensity acoustic stimulation during slow-wave sleep). The order in which each participant receives the two nights is randomized. A subset of participants additionally takes part in a later, exploratory closed-loop sub-study in which acoustic stimuli are triggered in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows.
| Arm | Type | Receives |
|---|---|---|
| DoA - No-Stimulation Night (Baseline) | No intervention | –Participants with DoA (N=55) undergo overnight high-density EEG and video-polysomnography with no acoustic stimulation. Within-subject baseline condition; order relative to Arm 2 is randomized per participant. |
| DoA - Acoustic Stimulation Night | Experimental | Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)The same DoA participants (N=55) undergo overnight high-density EEG and video-polysomnography with low-intensity open-loop acoustic stimulation delivered during slow-wave sleep; order relative to Arm 1 is randomized per participant. A subset of 10 participants additionally undergoes a later, exploratory real-time closed-loop stimulation sub-phase. |
| Healthy Control - Single Stimulation Night | Experimental | Device: Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)A separate group of healthy participants (N=5) undergoes a single overnight high-density EEG and video-polysomnography recording including open-loop acoustic stimulation during slow-wave sleep, to estimate the specificity of stimulation-elicited motor responses relative to the DoA group. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Diagnosis of a Disorder of Arousal (sleepwalking, sleep terror, or confusional arousal) per ICSD-3 criteria, confirmed by video-polysomnography or by clinical diagnosis plus a positive Arousal Disorders Questionnaire (ADQ) and compatible history
- Age 6-17 years (paediatric) or 18-60 years (adult) at enrollment
- At least one documented episode in the 4 weeks (paediatric) or 6 months (adult) prior to enrollment
- Ability to understand and complete study materials in Italian
- Written informed consent (and age-appropriate assent for minors, per Swiss Human Research Act Art. 22-23)
Key exclusion criteria (9 listed)
- Epilepsy or other major neurological disorder
- Comorbid REM sleep behavior disorder or other REM parasomnia
- Current psychopharmacological or psychotropic medication (except melatonin ≤2 mg)
- Neurodevelopmental disorder precluding protocol collaboration (paediatric participants)
- Clinically relevant sleep-disordered breathing (Apnea-Hypopnea Index >5 events/hour)
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 |
|---|---|---|
| Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)Brief, low-intensity auditory stimuli (pure tones or noise bursts, 50-70 dB SPL, approximately 1 second in duration) delivered via a standard speaker during confirmed slow-wave sleep (SWS). In the initial open-loop phase, stimuli are presented with randomized timing. In a later closed-loop sub-study, stimuli are triggered automatically in real time based on predefined EEG features, within randomized vulnerability versus refractory stimulation windows. Stimulation is immediately interrupted in the event of distress, full awakening, or any adverse reaction. | Device | DoA - Acoustic Stimulation Night, Healthy Control - Single Stimulation Night |
Primary outcome
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night
Time frame: Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks
Number of video-polysomnographically confirmed Disorders of Arousal (DoA) episodes (sleepwalking, sleep terror, or confusional arousal), compared within-subject between the stimulation night and the no-stimulation (baseline) night.
5 secondary outcomes
Duration of DoA Episodes (Seconds): Stimulation Night vs. No-Stimulation Night
Time frame: Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks.
Proportion of Slow-Wave Sleep Epochs With Successful Stimulation Trigger (Percentage)
Time frame: Assessed during the stimulation-night overnight recording, up to 6 weeks.
Visual Analogue Scale (VAS) Rating of Perceived Discomfort Related to Acoustic Stimulation
Time frame: Assessed the morning following the stimulation night, up to 6 weeks.
Arousal Index (EEG Arousals per Hour of Sleep): Stimulation Night vs. No-Stimulation Night
Time frame: Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
Sleep Efficiency (Percentage): Stimulation Night vs. No-Stimulation Night
Time frame: Assessed during both laboratory overnight recordings (no-stimulation night and stimulation night), up to 6 weeks.
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 10 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcome measures (high-density EEG recordings, episode classification, and questionnaire-derived measures) will be made available following publication of the primary results, in accordance with the SNSF Open Research Data policy and FAIR Data Principles ("as open as possible, as closed as necessary"). Derived and anonymized EEG datasets and analysis code will be deposited in FAIR-compliant, non-commercial repositories (e.g., OpenNeuro, Zenodo) with persistent identifiers, and released under a Creative Commons Attribution license (CC BY 4.0), unless stronger restrictions are required. Raw high-density EEG with synchronized video cannot be made openly available, as full anonymization is not feasible; these data will be deposited only in repositories supporting controlled access (e.g., EBRAINS), with access granted upon reasoned request to a Data Access Committee, subject to a Data Use Agreement and complian
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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.
Anna Castelnovo principal investigator
Neurocenter of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-Loop/Open-Loop Acoustic Stimulation (CLAS) in people with NREM Parasomnias and Sleepwalking, run by Anna Castelnovo at 1 site in Switzerland.
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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Aug 2026. 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 Switzerland. 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 Anna Castelnovo, MD, PhD (0041 918116117, anna.castelnovo@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of DoA Episodes During the Stimulation Night Compared With the No-Stimulation Night (time frame: Assessed during the two laboratory overnight recordings (no-stimulation night and stimulation night), at least 48 hours apart, up to 6 weeks). 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 10 Aug 2026.