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Subcortical Oscillations in Human Sleep Dysregulation

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ClinicalTrials.gov Identifier: NCT03377569
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment
Parkinson Disease REM Behavior Disorder Other: Sleep, PD and DBS

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 Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.
Actual Study Start Date : February 27, 2018
Actual Primary Completion Date : April 2, 2020
Actual Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group #1
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.
 Other: Sleep, PD and DBS
Sleep, PD and DBS
Group #2
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.
 Other: Sleep, PD and DBS
Sleep, PD and DBS
Group #3
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.
 Other: Sleep, PD and DBS
Sleep, PD and DBS


Outcome Measures
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Primary Outcome Measures :
  1. Measuring brain physiological activity via local field potentials and correlation to sleep states (REM, non-REM, etc.) [ Time Frame: One entire sleep cycle (each cycle is 8-10 hours). ]
    STN LFP activity will be measured by externalized DBS electrodes during in patient polysomnography.

  2. Chronic actigraphy to characterize sleep-wake behavior [ Time Frame: 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.

  3. Test the functional impact of STN-DBS on sleep-wake behavior through actigraphy [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377569


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: John A Thompson, Ph.D. Principal Investigator
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03377569    
Other Study ID Numbers: 17-0868
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Deep Brain Stimulation
Polysomnography
Actigraphy
Additional relevant MeSH terms:
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Parkinson Disease
REM Sleep Behavior Disorder
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders