Parkinson DiseaseNCT03377569
Subcortical Oscillations in Human Sleep Dysregulation
An observational study of Parkinson Disease and REM Behavior Disorder, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, REM Behavior Disorder
- What is being tested?
- Sleep, PD and DBS
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- Have a computer and be willing to use it as part of this study.
- Be able to learn to use and maintain a wristband-style sleep monitor.
- Turn off their Implantable Pulse Generator (IPG, implanted battery).
- Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.
- Spend one overnight research stay in the UCH Sleep lab, 3 weeks prior to DBS surgery .
Show all 12Show fewer
- Spend one overnight research stay in the UCH Sleep lab, immediately prior to IPG surgery, to record brain activity from the DBS electrode .
- Have a 15 minute surgery to externalize the DBS lead cable to allow overnight recordings to occur.
- Be pseudo-randomized to one of 2 conditions: OFF stimulation or ON stimulation.
- Wear a wristband-style sleep monitor for 3 weeks, 3 months post-DBS surgery, in one of the 2 pseudo-randomized conditions.
- 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.
Who cannot join
- Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital.
- Subjects without a documented sleep disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.
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.
Read the 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.
- Conditions
- Parkinson Disease, REM Behavior Disorder
- Being tested
- Sleep, PD and DBS
- Keywords
- Deep Brain Stimulation, Polysomnography, Actigraphy
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep, PD and DBSOther
Sleep, PD and DBS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: Sleep, PD and DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One entire sleep cycle (each cycle is 8-10 hours).
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start27 Feb 2018
- Primary completion2 Aug 2020
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Thompson, Ph.D., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377569
- Sponsor's protocol ID
- 17-0868
- Status last verified
- May 2024
- First submitted
- 29 Nov 2017
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.
- ClinicalTrials.gov ID
- NCT03377569
- Acronym / sponsor ID
- 17-0868
- Conditions
- Parkinson Disease, REM Behavior Disorder
- Keywords
- Deep Brain Stimulation, Polysomnography, Actigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group #1 | – | Other: Sleep, PD and DBSPatients 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 #2 | – | Other: Sleep, PD and DBSPatients 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. |
| Group #3 | – | Other: Sleep, PD and DBSPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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:
- Have a computer and be willing to use it as part of this study.
- Be able to learn to use and maintain a wristband-style sleep monitor.
- Turn off their Implantable Pulse Generator (IPG, implanted battery).
- Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.
Key exclusion criteria (2 listed)
- Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital.
- Subjects without a documented sleep disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep, PD and DBSSleep, PD and DBS | Other | Group #1, Group #2, Group #3 |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Thompson, Ph.D. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and REM Behavior Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.