BridgeMD
New treatment option for Parkinson Disease
Official title Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
ClinicalTrials.gov ID: NCT07355842
What this study is testing
- What it's testing
- This study tests whether enhancing deep sleep with gentle sounds at night can slow progression in people with iRBD or early Parkinson's disease. Participants wear a sensor headband and headphones for 18 months.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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 are:
- no dopaminergic treatment and no foreseen start of such treatment during duration of the study
You likely can't join if
- 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
See the full eligibility 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.