Influence of acoustic deep sleep enhancement on symptoms and laboratory parameters in patients with Parkinson's disease and mild cognitive impairment
Zusammenfassung der Studie
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. Mild cognitive impairment (MCI), typically the amnestic type (aMCI), often precedes Alzheimer's disease. Excessive daytime sleepiness is a common and difficult-to-treat symptom in PD patients that has a strong impact on many other symptoms and quality of life as such. Sleep disturbances are also common in MCI patients and can exacerbate cognitive impairment and psychological symptoms. Both diseases are progressive, as there are only selectively symptomatic, not etiological treatments. Our group provided class I evidence that the drug sodium oxybate improves excessive daytime sleepiness in PD patients by promoting deep sleep. Acoustic stimulation is a new, non-invasive method for enhancing deep sleep. The study is a randomized, double-blind, placebo-controlled crossover study to assess the non-pharmacological improvement of deep sleep in PD and MCI patients through acoustic stimulation. Both patient populations will be randomized into two groups: Group 1 will initially be treated for 2 weeks with acoustic stimulation and - after a washout period of 2-4 weeks - switched to a two-week placebo stimulation. Group 2 will initially receive a two-week placebo stimulation and then switch to a two-week treatment with acoustic stimulation. The primary outcome is the objectively measured differences in excessive daytime sleepiness in PD patients and memory function in MCI patients after two weeks of stimulation versus placebo stimulation. Secondary outcomes are changes in subjective momentary sleepiness throughout the day, vigilance, restorative quality of nighttime sleep, and biomarker levels in the blood.
(BASEC)
Untersuchte Intervention
Patients receive acoustic stimulation every night during sleep for two weeks using a portable, safe home device (TSB Axo). This medical device records biosignals (EEG) and plays precise sounds (approximately 50 dB, max. 80 dB) that are time-synchronized with the upward phase of deep sleep waves.
(BASEC)
Untersuchte Krankheit(en)
Parkinson's disease (also known as Morbus Parkinson or idiopathic Parkinson's syndrome) or mild cognitive impairment (also known as mild cognitive impairment, MCI)
(BASEC)
- Diagnosis of Parkinson's disease (PD; also known as Morbus Parkinson or idiopathic Parkinson's syndrome) or diagnosis of mild cognitive impairment (MCI; English Mild Cognitive Impairment), according to international criteria. - for PD: mild to moderate disease severity (Hoehn and Yahr scale II-III) - for MCI: predominant amnestic presentation (single or multi-domain aMCI) (BASEC)
Ausschlusskriterien
- Severe illnesses such as renal failure, liver failure, or congestive heart failure - Pregnant and breastfeeding women - for PD: deep brain stimulator (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Department of Neurology, University Hospital Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Angelina Maric
+41 44 255 86 15
angelina.maric@clutterusz.chDepartment of Neurology, University Hospital Zurich
(BASEC)
Allgemeine Auskünfte
University of Zurich
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.01.2021
(BASEC)
ICTRP Studien-ID
NCT04736017 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Assessing Effects of Auditory Slow Wave Enhancement on Symptoms and Biomarker Levels in Parkinson Disease and Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo-Controlled Crossover Study (BASEC)
Wissenschaftlicher Titel
Assessing Effects of Auditory Slow Wave Enhancement on Symptoms and Biomarker Levels in Parkinson Disease and Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo- Controlled Crossover Study (ICTRP)
Öffentlicher Titel
Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment (ICTRP)
Untersuchte Krankheit(en)
Parkinson Disease
Mild Cognitive Impairment
(ICTRP)
Untersuchte Intervention
Device: TSB Axo
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- Travelling more than 2 time zones in the last month before intervention starts or
during intervention (start of intervention will be adapted to fit with this criteria)
- Substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day)
- High caffeine consumption (> 5 servings/day; including coffee, energy drink)
- Implanted deep brain stimulation electrodes
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female patients of childbearing potential, not
using and not willing to continue using a medically reliable method of contraception
for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Difference in objective EDS
Difference in verbal episodic memory performance
(ICTRP)
Quality of life (VAS)
Overnight restoration vigilance
Sleep intensity
Subjective nocturnal sleep quality
Overnight memory consolidation
Verbal episodic and visuospatial memory function
Executive Function and attention
Vigilance
Subjective EDS
Depressive symptoms
Digital biomarkers
Motor symptoms
Overnight restoration inhibitory control
Overnight restoration working memory
Focused motor assessment
Subjective momentary sleepiness
Subjective mood
Subjective sleep quality
Plasma biomarkers
Sustained attention
(ICTRP)
Registrierungsdatum
25.01.2021 (ICTRP)
Einschluss des ersten Teilnehmers
01.04.2021 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Angelina Maric, PhD, University of Zurich (ICTRP)
Sekundäre IDs
PDMCI-TS (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04736017 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar