Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment

NCT04736017 | Unknown

• 1 other identifier: PDMCI-TS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. Patients will be randomized to two groups: Group 1 will first be treated with auditory stimulation for two weeks and then - after a washout period - switched to two weeks of sham stimulation. Group 2 will first receive sham stimulation for two weeks and then - after a washout period - switch to two weeks of auditory stimulation treatment. The washout period in between will be 2-4 weeks.

Conditions

Parkinson Disease; Mild Cognitive Impairment

Keywords

Parkinson Disease; Mild Cognitive Impairment; Excessive Daytime Sleepiness; Sleep; Slow wave sleep; Auditory enhancement; Neurodegeneration; Cognition

Outcome Measures

Primary Outcomes (2)

• Difference in objective EDS

  Difference in objective excessive daytime sleepiness (EDS), measured with Multiple Sleep Latency Test (MSLT; minutes), in Parkinson patients

  assessed after each intervention (day 15 of each intervention)

• Difference in verbal episodic memory performance

  Difference in verbal episodic memory performance, measured with the Hopkins Verbal Learning Test (HVLT; score ranges from 0 to 12, higher scores indicate better performance) delayed recall, in Mild Cognitive Impairment patients

  assessed after each intervention (day 15 of each intervention)

Secondary Outcomes (20)

• Subjective EDS

  assessed before and after each intervention (day 1 and 15 of each intervention)

• Sustained attention

  assessed after each intervention (day 15 of each intervention)

• Vigilance

  assessed after each intervention (day 15 of each intervention)

• Subjective nocturnal sleep quality

  assessed before and after each intervention (day 1 and 15 of each intervention)

• Executive Function and attention

  assessed after each intervention (day 15 of each intervention)

Study Arms (2)

Verum

EXPERIMENTAL

The device records EEG and other biosignals throughout the night and scans these signals for slow waves associated with deep Non-Rapid Eye Movement (NREM) sleep. Upon recognition of such slow waves and fulfilment of other criteria, a tone is played via the headphones to stimulate and enhance slow waves without waking up the patient.

Device: TSB Axo

Sham

SHAM COMPARATOR

Playing no tones during NREM sleep but wearing the device and recording the biosignals over a period of 2 weeks, every night.

Device: TSB Axo

Interventions

TSB Axo DEVICE

The TSB Axo is a wearable biosignal recording device combined with an auditory stimulation. The device consists of pre-gelled biosignal electrodes, headphones integrated in a headband, and a biosignal processing module.

Sham; Verum

Eligibility Criteria

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

You may qualify if:

• PD: Diagnosis of PD along international criteria, with mild to moderate disease severity (Hoehn and Yahr scale, stages ll-lll)
• PD: Ability to apply the intervention for the duration of study
• MCI: Diagnosis of MCI along international criteria, with a predominant amnestic presentation (single- or multi-domain amnestic MCI)
• MCI: Presence of a cohabitant person who could assist with the application
• MCI: Ability to apply the intervention for the duration of study, with assistance of co-habitant if needed
• PD and MCI:
• Age above 18 years
• Informed consent as documented by signature
• Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
• Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
• Dosing of dopaminergic, cholinergic, and other PD or MCI medication must have been stable for at least 14 days prior to start of the first intervention
• Negative pregnancy test during screening (except in women who are surgically sterilized/hysterectomized or postmenopausal for longer than 1 year)

You may not qualify if:

• PD: Presence of neurologic, psychiatric, or sleep disorders (others than associated with PD)
• PD: Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
• PD: Cognitive impairment (Montréal Cognitive Assessment \[MoCA\] \<24)
• MCI: Present diagnosis of a neurological (other than MCI) or interfering psychiatric disease or sleep disorder (e.g. sleep apnoea syndrome, restless legs syndrome)
• PD and MCI:
• Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
• Regular use of the following drugs: Benzodiazepines and other central nervous system (CNS)-depressant substances, melatonin and other sleep inducing substances, approved drugs for Alzheimer-type dementia (acetylcholine-esterase inhibitor, memantine)
• Inability to hear the tones produced by the TSB Axo
• Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
• Known or suspected drug- or medication abuse
• Known or suspected non-compliance
• Participation in another study with investigational drug or investigational medical devices 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
• Shift work (work during the night)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Neurology department

Zurich, 8050, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Disorders of Excessive Somnolence; 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; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angelina Maric, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Horlacher, MD

CONTACT

+41432535022; jana.horlacher@usz.ch

Angelina Maric, PhD

CONTACT

+41442558615; angelina.maric@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized, double-blind, sham-controlled cross-over trial.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CH (1)