NCT04589182

Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease

Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease: A Randomized, Double-Blind and Placebo-Controlled Crossover Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Christian Baumann · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson Disease
• Mild Cognitive Impairment
• Huntington Disease

Interventions

Type	Name	Description
DEVICE	MHSL- SleepBand	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.
DEVICE	Sham	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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2020-10-19
• Last updated: 2021-07-06

Locations

1 site across 1 country: Switzerland