Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-60
SponsorAnna Castelnovo

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Closed-Loop/Open-Loop Acoustic Stimulation (CLAS)

Treatment groups

50 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Anna Castelnovo

Lead sponsor

Neurocenter of Southern Switzerland

Sponsor institution

Swiss National Science Foundation

Collaborator

University of Bologna

Collaborator

University of Wisconsin, Madison

Collaborator

University of the Italian Switzerland

Collaborator

University of Applied Sciences and Arts of Southern Switzerland

Collaborator