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)
- Registry Record Last Updated
- 2026-04-30 (3 months ago)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: injections, infusions, or blood draws, placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "dosing of dopaminergic and other PD treatment must have been stable for at least 14 days prior to the intervention period and will be expected to remain stable until the end of the study.")
- Thinking test (MoCA): MoCA memory and thinking score between 18 and 26 (criteria text: ", 2012): * - cognitive decline: gradual decline, in the context of established pd, in cognitive ability reported by either the patient or informant, or obser...")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial requires a MoCA thinking-test score between 18 and 26.
Locations
- University Hospital Zurich, Zurich, Canton of Zurich, Switzerland
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07441915. It is the one about "Improve deep sleep and thinking". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: You will have assessments before the intervention, after the 5-week intervention, and at a 3-month follow-up; each visit includes about half a day of assessments and an overnight stay. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- 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. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- How many visits does this trial involve?
- You will have assessments before the intervention, after the 5-week intervention, and at a 3-month follow-up; each visit includes about half a day of assessments and an overnight stay.
- 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.