Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment

Summary

Participation Requirements

Description

The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients with subjective excessive daytime sleepiness and patients with amnestic MCI. The screening phase includes entry questionnaires about inclusion...

The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients with subjective excessive daytime sleepiness and patients with amnestic MCI. The screening phase includes entry questionnaires about inclusion/exclusion criteria, sleep quality, chronotype, and handedness, and 1-3 screening nights at home with the TSB Axo, to allow for stimulation optimization. One of the screening nights will be extended to screen for sleep apnea and periodic limb movements during sleep using an ambulatory recording device. Upon final inclusion, 24 PD and 24 MCI patients will be enrolled in the study for an overall period of 6-8 weeks (not including screening phase). Patients will receive 2 weeks of auditory SWS enhancement and 2 weeks of sham stimulation (only device application, no tones played) in a counter-balanced cross-over design, with a 2-4 week washout period during cross-over. Study visits will be performed immediately before and after each intervention period, i.e. before and after 2 weeks of auditory stimulation or sham stimulation, respectively. Study visits will include standardized clinical examinations, symptom questionnaires, biofluid sampling (optional lumbar puncture [LP] after intervention, blood sampling before and after intervention) and screening for adverse events by a study physician. Study visits will take place at the Department of Neurology, University Hospital Zurich.

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