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
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