The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in Parkinson disease (PD) patients with disturbed nighttime sleep. Additionally, the investigators will assess the feasibility and efficacy of auditory slow-wave sleep (SWS) enhancement in Mild Cognitive Impairment (MCI) and Huntington Disease (HD) patients in a pilot study.
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in PD patients with disturbed nighttime sleep. Patients will be randomized to 2 groups: Group 1 will first be treated with auditory stimulation for 3 nights and then - after a wash-out period of 4 nights - switched to 3 nights of sham stimulation. Group 2 will first receive sham-stimulation for 3 nights and then switch to 3 nights of auditory stimulation treatment. The wash-out period in between will be 4 nights. Patients and investigators assessing the outcomes will be blinded to the conditions. All interventions will take place at the patients' homes. The pilot study is aimed at assessment of safety, tolerability, feasibility and efficacy of auditory SWS enhancement on measured outcomes in MCI and HD patients with disturbed nighttime sleep. Patients will be treated with verum or sham auditory stimulation for 2 consecutive nights. All interventions will take place at the patients' homes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
The MHSL-SleepBand (sleep headband) is easy to apply and only involves attachment of sticky electrodes on different locations on the face/behind ear to be able to measure EEG (electroencephalogram), EOG (electrooculogram) and EMG (electromyogram). Brief tones at a low volume (around 60 dB, comparable to conversation) will be applied, when slow waves are present in the course of the sleep period and other criteria are fulfilled. Auditory stimulation will start with a specific volume that has been adjusted to the individual hearing capacity (usually between 45-65 dB; maximum 80 dB). The stimulation is performed in a way that the general structure of sleep (e.g. duration, sleep cycling, etc.) is unchanged.
Playing no tones during non- Rapid Eye Movement (NREM) sleep but wearing the device and recording the biosignals over a period of 3 nights, every night.
University Hospital Zurich, Neurology department
Zurich, Canton of Zurich, Switzerland
RECRUITINGSubjective sleep quality
Changes in subjective sleep quality measured with adapted version of Parkinson Disease Sleep Scale (PDSS2), questions on a scale of 0-4, with 0 indicating better sleep
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Pilot study: feasibility of acoustic SWS enhancement
Feasibility of acoustic SWS enhancement in MCI and HD patients (enhancement of slow-waves measured with EEG)
Time frame: assessed after intervention (day 10)
Vigilance
Changes in vigilance measured using Psychomotor Vigilance Test (PVT)
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Sleep benefit on motor performance
Changes in motor performance assessed with focus motor assessment
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Momentary sleepiness
Changes in momentary sleepiness assessed with Karolinska Sleepiness Scale (KSS) on a scale 1-10, with 1 indicating extreme alertness and 10 indicating extreme sleepiness
Time frame: assessed before and after each intervention, and every morning and evening during the intervention (day 1 until 4, day 7 until 10)
Average sleepiness
Average sleepiness throughout the day measured with VAS on a scale 0-100, with 100 indicating extreme sleepiness
Time frame: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Mood
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in mood assessed with Visual Analog Scale (VAS) on a scale 0-100, with 100 indicating extremely good mood
Time frame: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Restorative effect of sleep
Changes in restorative effect of sleep using VAS, on a scale 0-100, with 100 indicating very refreshing sleep
Time frame: assessed every morning during the intervention (day 1 until 4, day 7 until 10)
Slow wave enhancement
Enhancement of slow waves with auditory stimulation, measured with EEG
Time frame: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Auditory stimulation algorithm performance
Performance of algorithm detecting and stimulating slow waves, measured with EEG
Time frame: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Pilot study: changes in mood
changes in mood assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extremely good mood
Time frame: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleep quality
changes in sleep quality assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extremely good sleep quality
Time frame: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleepiness
changes in sleepiness assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extreme sleepiness
Time frame: before and after intervention (day 1 and 4, day 7 and 10)