Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease (NCT04589182) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years
SexALL
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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…
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