Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment

Exclusion Criteria

• •PD: Presence of neurologic, psychiatric, or sleep disorders (others than associated with PD)
• •PD: Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
• •PD: Cognitive impairment (Montréal Cognitive Assessment \[MoCA\] \<24)
• •MCI: Present diagnosis of a neurological (other than MCI) or interfering psychiatric disease or sleep disorder (e.g. sleep apnoea syndrome, restless legs syndrome)
• •PD and MCI:
• •Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
• •Regular use of the following drugs: Benzodiazepines and other central nervous system (CNS)-depressant substances, melatonin and other sleep inducing substances, approved drugs for Alzheimer-type dementia (acetylcholine-esterase inhibitor, memantine)
• •Inability to hear the tones produced by the TSB Axo
• •Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
• •Known or suspected drug- or medication abuse
• •Known or suspected non-compliance
• •Participation in another study with investigational drug or investigational medical devices within the 30 days preceding and during the present study
• •Previous enrolment in the current study
• •Enrolment of the investigator, his/her family members, employees and other dependent persons
• •Shift work (work during the night)
• •Travelling more than 2 time zones in the last month before intervention starts or during intervention (start of intervention will be adapted to fit with this criteria)
• •Substance or alcohol abuse (i.e. \> 0.5 l wine or 1 l beer per day)
• •High caffeine consumption (\> 5 servings/day; including coffee, energy drink)
• •Implanted deep brain stimulation electrodes
• •Women who are pregnant or breast feeding
• •Intention to become pregnant during the course of the study
• •Lack of safe contraception, defined as: Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases