Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Presynaptic Dopaminergic Integrity
研究概览
简要总结
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. Four assessments including mobility, memory, imaging (PET/MRI), lumbar puncture, and blood tests are assessed.
详细描述
Many people with REM sleep behavior disorder (iRBD) develop Parkinson's disease or similar conditions over the years. To date, there is no effective method to prevent this transition. Animal experiments and observational studies in patients and older adults indicate that deeper sleep is associated with a slower progression of brain changes. In this study, we are now investigating whether enhancement of deep sleep using sounds during sleep can influence the progressive brain changes in iRBD or early Parkinson's disease.
Participants wear a headband with sensors and headphones for 18 months, which plays gentle sounds during sleep to enhance deep sleep. In addition, four examinations are carried out, including tests of mobility, memory, imaging (PET/MRI), a lumbar puncture, and blood sampling. Two of the examinations will take place at the University Hospital of Zurich, and two more can also be carried out at home if desired.
The aim is to investigate whether enhancement of deep sleep can help slow the progression of iRBD or early-stage Parkinson's disease. The study is double-blind and controlled, which means that neither the participants nor the researchers know who is receiving the active treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Verum arm
Nightly enhancement of slow waves through Phase Targeted Auditory Stimulation (PTAS) over 18 months.
干预措施: Tosoo Axora (Device)
Sham arm
Nightly application of tones that will be applied in a non-PTAS manner, resulting in no enhancement of slow waves over 18 months.
干预措施: Tosoo Axora (Device)
结局指标
主要结局
Presynaptic Dopaminergic Integrity
时间窗: assessed at Baseline Visit and Closeout Visit (after 18 months)
Striatal dopaminergic function as measured by high-resolution 18F-Fluorodopa (18F-DOPA)-PET imaging.
次要结局
- MDS-UPDRS Part III Score(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Purdue Pegboard Test Score(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Alternate Finger Tapping Test(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- UPDRS I.1 (subjective cognition)(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Montreal Cognitive Assessment (MoCA) Score(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout))
- Trail Making Test Part A(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Trail Making Test Part B(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Digit Span Forward(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Digit Span backward(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Stroop Test(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Verbal Fluency - Semantic(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- Benton Judgment of Line Orientation (BJLO)(assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)))
- LPS-4 Logical Reasoning(assessed at Baseline Visit and Closeout Visit (after 18 months))
- Rey-Taylor Complex Figure Test - Copy(assessed at Baseline Visit and Closeout Visit (after 18 months))
- Rey-Taylor Complex Figure Test - Recall(assessed at Baseline Visit and Closeout Visit (after 18 months))
- California Verbal Learning Test (CVLT)(assessed at Baseline Visit and Closeout Visit (after 18 months))
- Verbal Fluency - Phonemic(assessed at Baseline Visit and Closeout Visit (after 18 months))
- Boston Naming Test (BNT)(assessed at Baseline Visit and Closeout Visit (after 18 months))
- WAIS Similarities(assessed at Baseline Visit and Closeout Visit (after 18 months))