Clinical trial NCT03377569: Subcortical Oscillations in Human Sleep Dysregulation
Official title: Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
REM Behavior Disorder
Keywords: Deep Brain Stimulation
Polysomnography
Actigraphy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinsons Disease and a documented sleep disorder planning on undergoing bilateral Deep Brain Stimulation surgery at the University of Colorado Hospital.

Brief summary: Sleep problems are common in the United States (US) adult population (\>50 million), and have a negative impact on quality of life, productivity, and healthcare. A major obstacle to understanding how the brain is involved in human sleep disorders has been the lack of recordings of human brain function, from inside the brain, during the known sleep states.

Detailed description: Sleep is necessary for life; critically important to the regulation of body and brain function. Sleep problems are common in the U.S. adult population (\>50 million), and have a negative impact on quality of life, productivity, and healthcare. A major obstacle to understanding how the brain is involved in human sleep disorders has been the lack of recordings of brain function, from inside the brain, during the known sleep states; non-rapid eye movement (NREM) and rapid eye movement (REM). It is very common for patients with Parkinson's disease (PD) to also have sleep disorders, such as insomnia, restless-leg-syndrome and REM-behavior disorder. One treatment for PD patients is deep brain stimulation (DBS) of the subthalamic nucleus (STN-DBS). Despite evidence showing that STN-DBS improves several aspects of sleep behavior in PD subjects, few studies have examined the relationship between brain activity and sleep regulation in human subjects. In this proposal, the investigators will examine sleep in humans by recording brain activity from STN of PD patients who have undergone DBS surgery. The investigators will also test the hypothesis that STN contributes to both the regulation and disruption of normal sleep behavior.

Eligibility criteria: Inclusion Criteria:

Subjects with Parkinson's Disease (PD) who are planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital and willing and able to do the following:

1. Have a computer and be willing to use it as part of this study.
2. Be able to learn to use and maintain a wristband-style sleep monitor.
3. Turn off their Implantable Pulse Generator (IPG, implanted battery).
4. Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.
5. Spend one overnight research stay in the UCH Sleep lab, 3 weeks prior to DBS surgery .
6. Spend one overnight research stay in the UCH Sleep lab, immediately prior to IPG surgery, to record brain activity from the DBS electrode .
7. Have a 15 minute surgery to externalize the DBS lead cable to allow overnight recordings to occur.
8. Be pseudo-randomized to one of 2 conditions: OFF stimulation or ON stimulation.
9. Wear a wristband-style sleep monitor for 3 weeks, 3 months post-DBS surgery, in one of the 2 pseudo-randomized conditions.
10. Spend one overnight research stay in the UCH Sleep lab, 4 months post DBS surgery, in one of the pseudo-randomized conditions.

Subjects will have a sleep disorder documented in their medical history as determined by a single question screen for REM sleep behavior disorder.

Exclusion Criteria:

1. Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital.
2. Subjects without a documented sleep disorder.

Primary outcomes:
measure: Measuring brain physiological activity via local field potentials and correlation to sleep states (REM, non-REM, etc.)
timeFrame: One entire sleep cycle (each cycle is 8-10 hours).
measure: Chronic actigraphy to characterize sleep-wake behavior
timeFrame: 3 weeks
measure: Test the functional impact of STN-DBS on sleep-wake behavior through actigraphy
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: Principal Investigator
name: John A Thompson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: