Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05348837

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation

Study Details

Brief summary:

The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence and impact of non-motor symptoms become the focus of intense study. Disturbances of sleep are among the most common non-motor manifestations of PD; approximately two-thirds of PD patients experience sleep dysfunction of some kind. Given that sleep contributes to the regulation of many physiological processes, sleep disturbance has a significant impact on quality of life in PD, and places high strain on caregivers. Though numerous symptomatic therapies exist, the treatment of sleep disorders in PD is limited by a lack of adequately powered, randomized studies providing high quality evidence. Although deep brain stimulation (DBS) is primarily used to treat PD motor symptoms and reduce the need for dopaminergic medications, several studies have shown that DBS provides benefit for non-motor symptoms, including sleep disturbance. Few studies have used an objective measure to assess the impact of DBS on sleep in PD, and none have done so by studying sleep in the home environment. Existing studies have largely been limited to a single night of sleep recording in a sleep lab. Furthermore, no studies have assessed sleep both on and off medication, before and after DBS implantation. This study will enroll patients undergoing evaluation for DBS implantation. Sleep will be assessed before DBS implantation, both while patients continue their usual medication regimen and while withholding medications. After DBS implantation and programming, sleep will again be assessed with stimulation on, both while continuing medications and subsequently while withholding medications.

Conditions

Parkinson Disease

Study ID

NCT05348837

Start date

May 1, 2022

Status verified date

Dec, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Research subjects must be willing and able to do the following:

  • Be able to learn to use and maintain a wristband-style sleep monitor
  • Wear a wristband-style sleep monitor for two weeks
  • Be able to learn to use and maintain a headband sleep monitor
  • Wear a headband sleep monitor for two weeks
  • Log daily routine events, such sleeping, eating, and medication regimens for the two-week study period
  • Withhold dopaminergic medications after 5:00pm for three consecutive nights

Exclusion Criteria:

Subjects will be excluded if they:

  • Carry a diagnosis of dementia (e.g., Parkinson's Disease Dementia or Dementia with Lewy Bodies)
  • Currently use or recently (within past 30 days) used a sedative-hypnotic agent for sleep (e.g., Zolpidem, Suvorexant, Eszopiclone)
  • Fulfill criteria or carry a diagnosis of a circadian sleep-wake rhythm disorder, as defined by the International Classification of Sleep Disorders, Third Edition

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Subthalamic nucleus (STN) DBS

Patients undergoing evaluation for subthalamic nucleus DBS implantation will be included in this group.

Globus pallidus interna (GPi) DBS

Patients undergoing evaluation for globus pallidus interna DBS implantation will be included in this group.

Interventions

Deep brain stimulation

Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician.

Primary outcome measure

  • Change in total sleep time (TST) as measured by polysomnogram-capable headband [ Time Frame: Baseline; 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 4, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-04.