Sleep and adaptive DBS in Parkinson’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with Parkinson’s disease who have STN or GPi DBS and are using adaptive DBS in dual-threshold mode. Researchers will first collect baseline sleep and basal ganglia activity, then conduct 15 nights of at-home sleep monitoring with three sleep-tailored aDBS settings used only at night. Participants will choose their preferred setting, after which repeat polysomnography will compare sleep architecture and aDBS behavior against baseline. The study aims to link sleep-stage physiology with DBS modulation to potentially improve sleep and related cognitive outcomes in PD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients, in the age range of 45 to 75 years (inclusive)
* Have a smart phone and be willing and able to download the app required for the Waveband and SEMA3
* Are able to use the Waveband app
* Diagnosis of idiopathic PD and treatment with STN or GPi DBS using the Medtronic system, including SenSight (model B33005 or B33015) leads and Percept RC (model B35300) implanted pulse generator
* Hoehn and Yahr stage 2-3 (on medication, on DBS) at the time of enrollment
* Taking unchanged doses of antiparkinsonian medications for at least 4 weeks prior to study enrollment.
* Stable and optimized (for motor symptom control) DBS therapy settings, using adaptive DBS in the dual threshold mode. 'Stable and optimized 'will be defined by the following: 1) no changes made to DBS stimulation parameters within the last 30 days, and 2) improvement of PD motor symptoms, as determined by the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part III, of at least 30% between the stimulation off and on conditions.

Exclusion Criteria:

* Clinical diagnosis of dementia
* Current or recent (within the past 30 days) use a sedative-hypnotic drug (including medications known to affect SPs or SWs such as benzodiazepines40)
* Participants who fulfill criteria for or carry a diagnosis of a circadian sleep-wake disorder as defined by the International Classification of Sleep Disorders, 3rd Edition41
* Shift workers
* Presence of any other condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Neurology Recruitment Partner Neurology Recruitment Partner
• Email: Neuroresearch@cuanschutz.edu
• Phone: 3037244644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.