Subcortical Oscillations in Human Sleep Dysregulation

Active, not recruiting

• Conditions: REM Behavior Disorder; Parkinson Disease
• Interventions: Other: Sleep, PD and DBS

• Registration Number: NCT03377569
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Study Start: 2018-02-27
• Primary Completion: 2020-08-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group #1	Sleep, PD and DBS	Patients with Parkinsons Disease who will undergo Deep Brain Stimulation surgery. At home sleep monitoring prior to DBS surgery and in patient polysomnography with neural recording after DBS surgery.
Group #3	Sleep, PD and DBS	Patients with Parkinsons Disease who will undergo Deep Brain Stimulation surgery. At home sleep monitoring after DBS surgery with DBS stimulation off at night, and in patient polysomnography after DBS surgery.
Group #2	Sleep, PD and DBS	Patients with Parkinsons Disease who will undergo Deep Brain Stimulation surgery. At home sleep monitoring after DBS surgery with DBS stimulation on at night, and in patient polysomnography after DBS surgery.

Primary Outcome Measures

Name	Time	Method
Chronic actigraphy to characterize sleep-wake behavior	3 weeks	The investigators will collect typical sleep-wake behavior-including indirect features of sleep disturbance-by equipping patients with a sleep-monitoring device (ActiGraph AW2) that will record sleep parameters.
Measuring brain physiological activity via local field potentials and correlation to sleep states (REM, non-REM, etc.)	One entire sleep cycle (each cycle is 8-10 hours).	STN LFP activity will be measured by externalized DBS electrodes during in patient polysomnography.
Test the functional impact of STN-DBS on sleep-wake behavior through actigraphy	3 weeks	The investigators will examine the impact of STN modulation, via DBS in both On- and Off-Stimulation conditions in separate groups of subjects, on typical sleep-wake behavior.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States