Subcortical Oscillations in Human Sleep Dysregulation

Parkinson Disease Clinical Trial

Official title:

Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03377569
• Other study ID #: 17-0868
• Status: Active, not recruiting
• Start date: February 27, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: August 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• REM Behavior Disorder
• REM Sleep Behavior Disorder

Intervention

Other:
• Sleep, PD and DBS
Sleep, PD and DBS

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring brain physiological activity via local field potentials and correlation to sleep states (REM, non-REM, etc.)	STN LFP activity will be measured by externalized DBS electrodes during in patient polysomnography.	One entire sleep cycle (each cycle is 8-10 hours).
Primary	Chronic actigraphy to characterize sleep-wake behavior	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.	3 weeks
Primary	Test the functional impact of STN-DBS on sleep-wake behavior through actigraphy	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.	3 weeks