Phase-Targeted Auditory Stimulation for Parkinson's (NCT07441915)
Improve deep sleep and thinking
- Trial ID
- NCT07441915
- Official Title
- Non-pharmacological Enhancement of Deep Sleep With Auditory Stimulation Versus Sham in People With Parkinson's Disease and Mild Cognitive Impairment Receiving Cognitive Training: A Double-blind Randomized Trial (PD-CogT-Sleep)
- Goal
- Improve deep sleep and thinking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Zurich
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Interventions
- Phase-Targeted Auditory Stimulation (PTAS), Digital Cognitive Training (CogT)
Summary For Families
It aims to boost deep, slow-wave sleep to support memory and cognitive function in people with Parkinson's who have mild cognitive impairment. The approach uses phase-targeted auditory stimulation, gentle tones played by a sleep headband (TOSOO Axora) timed to the brain's slow waves to amplify slow-wave activity and help sleep-related memory consolidation, paired with nightly digital cognitive training; because it is non-drug it does not interact with levodopa, though participants must keep their Parkinson's medications stable during the trial. Looking for adults 18 and older with Parkinson's and MCI (MoCA 18,26), who can follow German procedures and apply the home-based sleep and cognitive interventions, and who do not have dementia, significant sleep apnea, regular benzodiazepine use, or other major medical or psychiatric exclusions.
Locations
- University Hospital Zurich, Zurich, Canton of Zurich, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Phase-Targeted Auditory Stimulation (PTAS). It aims to boost deep, slow-wave sleep to support memory and cognitive function in people with Parkinson's who have mild cognitive impairment. The approach uses phase-targeted auditory stimulation, gentle tones played by a sleep headband (TOSOO Axora) timed to the brain's slow waves to amplify slow-wave activity and help sleep-related memory consolidation, paired with nightly digital cognitive training; because it is non-drug it does not interact with levodopa, though participants must keep their Parkinson's medications stable during the trial. Looking for adults 18 and older with Parkinson's and MCI (MoCA 18,26), who can follow German procedures and apply the home-based sleep and cognitive interventions, and who do not have dementia, significant sleep apnea, regular benzodiazepine use, or other major medical or psychiatric exclusions.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 7 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will attend three assessment visits: before the intervention, after the intervention, and again three months later; each assessment includes one overnight stay at University Hospital Zurich.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); Wearable / at-home monitoring (non-invasive); Brain wave recording (EEG) (non-invasive); Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.