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Can gentle sounds unlock the mystery of sleepwalking?

NCT ID NCT07754838

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study investigates whether playing soft sounds during deep sleep can help researchers understand and possibly influence episodes of sleepwalking, sleep terrors, and confusional arousals—conditions known as disorders of arousal. Participants with these conditions will spend two nights in a sleep lab, one with sound stimulation and one without, to compare how often and how long episodes occur. A small group of healthy volunteers will also undergo a single night of sound stimulation to see if the effects are specific to people with these disorders. The sounds are very quiet, similar to normal conversation, and are stopped immediately if any discomfort occurs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Closed-loop and open-loop acoustic stimulation (soft sounds played during deep sleep)
What this could lead to
If successful, this could reveal what triggers sleepwalking and related episodes, and potentially point toward a sound-based method to study or manage these conditions.
What could go wrong
This is an early, exploratory study with a small number of participants. The sounds may not reliably trigger or modulate episodes, and results may not apply to everyone with these sleep disorders.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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) 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 Exclusion Criteria (all participants): * 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 * 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

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Conditions

The condition(s) this trial relates to.

Night Terrors parasomnia, sleep terrors type parasomnia, sleepwalking type Parasomnias Sleep Arousal Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ospedale Italiano di Lugano

    Lugano, Canton Ticino, 6962, Switzerland

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