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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Procedure | Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep time (TST) as measured by polysomnogram-capable headband | The total amount of time spent asleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France). | Baseline; 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep efficiency (SE) as measured by polysomnogram-capable headband | SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France). | Baseline; 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) score | The PSQI is a well-validated clinical questionnaire that queries subjects on seven sleep parameters. | Baseline; 6 months |
| Change in Parkinson Disease Sleep Scale, version 2 (PDSS-2) score |
Inclusion Criteria:
Research subjects must be willing and able to do the following:
Exclusion Criteria:
Subjects will be excluded if they:
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Patients undergoing evaluation for DBS candidacy are eligible to participate in this study. Those deemed appropriate for DBS implantation and who undergo bilateral DBS will complete the second (post-operative) phase of the study. Candidacy for DBS implantation will be determined by the treating team, which includes a neurologist, neurosurgeon, neuropsychologist, neuro-radiologist, and palliative care physician. Decision to participate in the study will have no bearing on DBS candidacy. Patients are eligible to participate in this study regardless of device being implanted.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Hirt | Contact | 720-848-2080 | lisa.hirt@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Baumgartner, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Change in sleep onset latency (SOL) as measured by polysomnogram-capable headband |
SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France). |
| Baseline; 6 months |
| Change in wake after sleep onset (WASO) as measured by polysomnogram-capable headband | WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by a polysomnogram-capable headband (Dreem Headband, Rythm, France). | Baseline; 6 months |
| Change in total sleep time (TST) as measured by actigraphy | Total amount of time spent asleep, averaged over the 3-night study period, will be measured by actigraphy | Baseline; 6 months |
| Change in sleep efficiency (SE) as measured by actigraphy | SE, defined as the amount of time spent asleep divided by the amount of time spent in bed, averaged over the 3-night study period, will be measured by actigraphy. | Baseline; 6 months |
| Change in sleep onset latency (SOL) as measured by actigraphy | SOL, defined as the amount of time between lying in bed to attempt to sleep and the onset of sleep, averaged over the 3-night study period, will be measured by actigraphy. | Baseline; 6 months |
| Change in wake after sleep onset (WASO) as measured by actigraphy | WASO, defined as the amount of time spent awake after the initial onset of sleep, averaged over the 3-night study period, will be measured by actigraphy. | Baseline; 6 months |
The PDSS-2 is a 15-item scale which specifically queries several sleep disturbances commonly afflicting PD patients, including restless leg syndrome, nocturia, pain, and sleep apnea
| Baseline; 6 months |
| Change in Fatigue Severity Scale (FSS) score | The FSS is a nine-item scale that measures the severity of fatigue and its impact on daily life. | Baseline; 6 months |
| Change in Epworth Sleepiness Scale (ESS) score | The ESS is a self-administered, eight-item assessment of daytime sleepiness. | Baseline; 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |