Gentle nighttime sounds to boost deep sleep and slow brain changes in iRBD and early Parkinson's
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
NA · University of Zurich · NCT07355842
This test will see if playing gentle sounds during sleep can boost deep slow-wave sleep and slow brain changes in people with isolated REM sleep behavior disorder or early Parkinson's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | University of Zurich (other) |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT07355842 on ClinicalTrials.gov |
What this trial studies
Participants wear a sensor headband and headphones nightly for 18 months while receiving either timed gentle auditory stimulation or a control condition in a double-blind, controlled design. The protocol includes four comprehensive assessments of motor function, cognition, PET/MRI imaging, lumbar puncture, and blood biomarkers, with two visits at University Hospital Zurich and two that can be done at home. Eligible participants have polysomnography-confirmed iRBD with early motor/olfactory signs or a Parkinson's diagnosis under two years and must not be on dopaminergic therapy during the study. Outcomes combine imaging and biomarker changes with mobility and cognitive measures to determine whether boosting slow-wave sleep alters disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults with polysomnography-confirmed iRBD plus early motor or olfactory signs, or people diagnosed with Parkinson's within the past two years, who are not taking dopaminergic medications and can use the headband and headphones and speak German, French, or Italian.
Not a fit: People with significant hearing loss that prevents hearing the tones, those who fail the auditory stimulation screening, patients already taking or planning to start dopaminergic therapy during the study, or those with advanced Parkinson's are unlikely to benefit.
Why it matters
Potential benefit: If successful, this noninvasive approach could slow neurodegenerative changes and delay progression from iRBD to Parkinson's or slow worsening in early Parkinson's disease.
How similar studies have performed: Animal studies and observational human data link deeper slow-wave sleep to slower brain changes, and small trials in older adults have shown auditory stimulation can enhance slow waves, but its effect on neurodegenerative progression in iRBD or early Parkinson's is not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Diagnosis of polysomnography-confirmed isolated REM Sleep Behavior Disorder (iRBD) based on international criteria (ICSD-3), combined with EITHER * UPDRS III without action tremor ≥ 4 AND abnormal olfaction, OR * diagnosis of PD along international criteria for less than 2 years Further inclusion criteria are: * no dopaminergic treatment and no foreseen start of such treatment during duration of the study * ability to apply the intervention, alone or with help of a co-habitant, stable living situation * sufficient language skills in German, French or Italian * negative pregnancy test for women of child-bearing potential Exclusion Criteria: * Suspected or known non-compliance to other therapies * current or recent participation in another clinical trial * extended absences * hearing impairment that prevents hearing the tones for auditory stimulation * non-responder to auditory stimulation during screening * clinically significant concomitant disease or unstable condition * Apnea-Hypopnea-Index (AHI) \> 15/h or under Continuous Positive Airway Pressure (CPAP) treatment * Restless Legs Syndrome * meeting criteria for diagnosis of atypical Parkinson syndrome * diagnosis of Dementia or Montreal Cognitive Assessment (MoCA) \< 24 * severe Depression or other psychiatric disorder * regular use of benzodiazepines and other central nervous system depressant substances * current or recent history within the last year of substance abuse disorders or chronic alcohol consumption * recent or planned major surgery * history of allergies and hypersensitivity relevant for electrode application or medication allergies * additional exclusion criteria for PET imaging * any criterion that may pose the participant at risk * breastfeeding, intention to become pregnant, or unwillingness to use medically reliable contraception for women of child-bearing potential
Where this trial is running
Zurich, Canton of Zurich
- University Hospital Zurich, Neurology Department — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Andreas Luft, Prof. Dr. med. — University of Zurich
- Study coordinator: Jana Bünzli, MSc
- Email: jana.buenzli@usz.ch
- Phone: +41 44 255 10 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, REM Sleep Behavior Disorder, Parkinson, Parkinson disease, Sleep, Neurodegeneration, Auditory stimulation, iRBD