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Can brain stimulation be tuned to improve sleep in Parkinson's?

NCT ID NCT07808346

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adjusting deep brain stimulation (DBS) settings specifically for sleep can improve sleep quality in people with Parkinson's disease. Participants already use an adaptive DBS system that responds to brain signals. Researchers will compare three different sleep-tailored settings over 15 nights to see which one people prefer and how it affects brain activity and sleep patterns. The goal is to find a way to make nighttime stimulation work better for sleep without compromising daytime benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive deep brain stimulation (aDBS) with three different sleep-tailored settings
What this could lead to
If it works, this could point toward a way to improve sleep quality and nighttime brain activity for people with Parkinson's disease who already use DBS.
What could go wrong
This is a small, early-stage study with only 18 participants, so results may not apply to everyone. The benefit may be modest, and adjusting DBS settings carries risks like discomfort or changes in symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease (PD)

Contacts and locations

Locations

  • University of Colorado

    Aurora, Colorado, 80045, United States

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