Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease (NCT04589182) | Clinical Trial Compass
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Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease
Switzerland12 participantsStarted 2020-10-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-Sle…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective sleep quality
Timeframe: assessed before and after each intervention (day 1 and 4, day 7 and 10)
2
Pilot study: feasibility of acoustic SWS enhancement