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

NCT04589182 | Unknown

• 1 other identifier: PDSL-EDS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Mild Cognitive Impairment; Huntington Disease

Keywords

sleep; neurodegeneration; slow- wave sleep

Outcome Measures

Primary Outcomes (2)

• Subjective 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

  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)

  assessed after intervention (day 10)

Secondary Outcomes (11)

• Vigilance

  assessed before and after each intervention (day 1 and 4, day 7 and 10)

• Sleep benefit on motor performance

  assessed before and after each intervention (day 1 and 4, day 7 and 10)

• Momentary sleepiness

  assessed before and after each intervention, and every morning and evening during the intervention (day 1 until 4, day 7 until 10)

• Average sleepiness

  assessed every evening during the intervention (day 1 until 4, day 7 until 10)

• Mood

  assessed every evening during the intervention (day 1 until 4, day 7 until 10)

Study Arms (2)

Verum

EXPERIMENTAL

Patients will receive all-night auditory stimulation during sleep over 3 nights using a portable, safe, in-home device (MSHL-SleepBand). This device records biosignals (EEG) and precisely plays tones (between 45-65 dB, maximum 80 dB) targetted to the up-phase of sleep slow waves.

Device: MHSL- SleepBand

Sham

SHAM COMPARATOR

Patients will receive all-night sham stimulation over 3 nights, i.e. the wearable stimulation device will be applied (EEG will be recorded), but no tones will be played.

Device: Sham

Interventions

MHSL- SleepBand DEVICE

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.

Also known as: Auditory SWS stimulation

Verum

Sham DEVICE

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.

Also known as: Sham stimulation

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent as documented by signature
• Diagnosis of PD along international criteria with mild to moderate disease severity (Hoehn- Yahr (HY) stages ll-lll),
• Self-reported sleep problems and subjectively impaired sleep quality (PDSS-2 sleep quality subscale (items 1-3 and 14) ≥7)
• Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
• Ability to apply the intervention for the duration of study, either alone or with help of co-habitant
• Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
• Dosing of dopaminergic and other PD treatment must have been stable for at least 14 days prior to the first intervention period
• Negative pregnancy test during screening (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year),
• Age above 18 years

You may not qualify if:

• Known presence of neurologic (other than PD), psychiatric, or sleep disorders (others than associated with PD)
• Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
• Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
• The regular use of benzodiazepines and other central nervous system (CNS)-depressant substances, as well as melatonin and other sleep inducing substances
• Inability to hear the tones produced by the MHSL-SleepBand device
• Absence of slow-wave enhancement by auditory stimulation during the screening night
• Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
• Failure to give informed consent
• Known or suspected drug- or medication abuse
• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
• Cognitive impairment (Montreal Cognitive Assessment - MoCA \<24)
• Participation in another study with investigational drug 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

Sponsors & Collaborators

• Christian Baumann: lead
• ETH Zurich: collaborator

Study Sites (1)

University Hospital Zurich, Neurology department

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Huntington Disease; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simon Schreiner, MD

CONTACT

+41 44 355 55 11; simon.schreiner@usz.ch

Angelina Maric, PhD

CONTACT

+41 44 255 86 15; Angelina.maric@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: During data collection, patients will be blinded to the condition. The leading experimenter will be unblind and have access to the keys that define whether the interventions, namely intervention 1 and intervention 2, are sham or verum. However, all experimenters will be blinded for analysis of outcome measures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: randomized, double-blind, sham-controlled cross-over trial

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-06

Locations

CH (1)