Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease: A Randomized, Double-Blind and Placebo-Controlled Crossover Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Christian Baumann
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Subjective sleep quality
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Christian Baumann
Professor
University of Zurich
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Subjective sleep quality
Time Frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
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
Pilot study: feasibility of acoustic SWS enhancement
Time Frame: assessed after intervention (day 10)
Feasibility of acoustic SWS enhancement in MCI and HD patients (enhancement of slow-waves measured with EEG)
Secondary Outcomes
- 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))
- 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))
- Auditory stimulation algorithm performance(assessed every night of the intervention (day 1 until 4, day 7 until 10))
- Restorative effect of sleep(assessed every morning during the intervention (day 1 until 4, day 7 until 10))
- Slow wave enhancement(assessed every night of the intervention (day 1 until 4, day 7 until 10))
- Pilot study: changes in mood(before and after intervention (day 1 and 4, day 7 and 10))
- Pilot study: changes in sleepiness(before and after 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))
- Pilot study: changes in sleep quality(before and after intervention (day 1 and 4, day 7 and 10))