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Integration of Auditory, and Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease

NCT05184270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-21

No results posted yet for this study

Summary

The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Acoustic stimulation

In this project, the intervention is a presentation of low-volume non-arousing auditory stimuli during deep NREM sleep via attached headphones. Stimuli will be applied targeting the up-phase of slow waves to enhance sleep slow-wave activity. Previous studies showed that this procedure does not lead to reduced sleep quality nor result in changed sleep architecture. Therefore, no negative consequences as a result of our intervention are to be expected. In fact, it is currently applied in several other studies including children, adults, and the elderly. Importantly, stimulation is not arousing, as the sounds presented during deep sleep are brief (50 ms) and at low volume (around 50 dB). In case of arousal during sleep (detected using the surface EEG signal), the volume will be adjusted.

Sponsors & Collaborators

  • Klinik Lengg, Zurich

    collaborator OTHER

  • University Children's Hospital

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • Christian Baumann

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2023-03-07
Completion
2023-03-07

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184270 on ClinicalTrials.gov