---
title: Improve deep sleep and thinking
nct_id: NCT07441915
phase: NA
status: RECRUITING
sponsor: University of Zurich
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07441915"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07441915"
last_fetched: "2026-05-10T14:07:10.016Z"
source: "Parkinson's Pathways (curated)"
---
# Improve deep sleep and thinking

**Goal (in five words):** Improve deep sleep and thinking

**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)

**Trial ID:** [NCT07441915](https://clinicaltrials.gov/study/NCT07441915)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University of Zurich
- **Target Enrollment:** 50 participants
- **Start Date:** 2026-04-22
- **Completion Date:** 2027-12
- **Conditions:** Parkinson's Disease, Mild Cognitive Impairment
- **Interventions:** Phase-Targeted Auditory Stimulation (PTAS), Digital Cognitive Training (CogT)
- **Intervention Types:** DEVICE, OTHER

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* clinical diagnosis of PD along the MDS criteria (Postuma et al., 2015)
* MCI according to the MDS criteria, level I (Litvan et al., 2012):
* \- cognitive decline: Gradual decline, in the context of established PD, in cognitive ability reported by either the patient or informant, or observed by the clinician, AND
* \- MoCA ≤ 26 and ≥ 18 (Hoops et al., 2009)
* 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 sleep intervention for the duration of study, either alone or with assistance of a co-habitant if needed
* ability to apply the CogT intervention for the duration of study
* 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 intervention period and will be expected to remain stable until the end of the study.

Exclusion Criteria:

Diagnosis/Comorbidities:

* clinical diagnosis of dementia (cognitive impairment sufficient to interfere with independence in everyday activities, i.e. "major neurocognitive disorder", DSM-5)
* known presence of neurologic (other than PD) or psychiatric disorder
* Parkinsonism without response to levodopa; atypical Parkinsonian syndromes as assessed from medical history and clinical examination
* severe medical conditions (for example, renal insufficiency, liver failure, or congestive heart failure) as assessed in the semi-structured screening interview
* regular use of benzodiazepines and other central nervous system (CNS)-depressant substances as assessed in the semi-structured screening interview
* known or suspected drug- or medication abuse as assessed in the semi-structured screening interview
* substance or alcohol abuse (i.e. \> 0.5 l wine or 1 l beer per day) as assessed in the semi-structured screening interview

Sleep disorders that could interfere with the sleep intervention:

* obstructive sleep apnea with apnea-hypopnea index (AHI)\>15, apnea-related NREM sleep fragmentation, and indication for treatment (in turn, primarily REM-related sleep apnea, not requiring specific treatment may be considered eligible); or use of continuous positive airway pressure (CPAP)
* Restless Legs Syndrome
* frequent (i.e. weekly) Non-REM sleep parasomnia (Sleep disorders typically associated with PD will not lead to exclusion, i.e. REM sleep behavior disorder, insomnia, nocturnal PD symptoms.)

PTAS:

* inability to hear the tones produced by the sleep headband (TOSOO Axora device)
* non-responder to PTAS during screening (PTAS does not evoke a discernable auditory evoked potential AEP)
* skin disorders/problems/allergies in face/ear area that could worsen with electrode application
* known or suspected non-compliance

Cognition \& informed consent:

* inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
* failure to give informed consent

Other studies:

* participation in another study with investigational interventions within 30 days (PTAS) or 1 year (CogT) preceding and during the present study
* previous enrolment in the current study
* enrolment of the investigator, his/her family members, employees and other dependent persons

Special events / behavior with impact on circadian rhythm, sleep, or cognition:

* shift work (work during the night)
* travelling more than 2 time zones in the last month before intervention starts or during intervention (start of intervention will be adapted to fit with this criteria)
* planned medical intervention of substantial relevance, e.g. surgery, during intervention (routine assessments, e.g. check-ups will be allowed)

Pregnancy:

* women who are pregnant or breastfeeding,
* intention to become pregnant during the course of the study,
* lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
```

## Locations (1)

- University Hospital Zurich, Zurich, Canton of Zurich, Switzerland _(47.3667, 8.5500)_
  - Department of Neurology — (CONTACT) — +41 44 255 55 11 — neurologie@usz.ch

## Central Contacts

- Simon J. Schreiner, MD — (CONTACT) — +41 43 253 24 18 — simon.schreiner@usz.ch
- Marie Therese Kleinsorge, MD — (CONTACT) — +41 43 253 13 10 — marie.kleinsorge@usz.ch

---

*Canonical: https://parkinsonspathways.com/trial/NCT07441915*  
*HTML version: https://parkinsonspathways.com/trial/NCT07441915*  
*Source data: https://clinicaltrials.gov/study/NCT07441915*