Subcortical Oscillations in Human Sleep Dysregulation

NCT03377569 | Active Not Recruiting

• 1 other identifier: 17-0868
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; REM Behavior Disorder

Keywords

Deep Brain Stimulation; Polysomnography; Actigraphy

Outcome Measures

Primary Outcomes (3)

• 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).

• 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

• 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

Study Arms (3)

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

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

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

Interventions

Sleep, PD and DBS OTHER

Sleep, PD and DBS

Group #1; Group #2; Group #3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 .
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Interventions

Sleep

Condition Hierarchy (Ancestors)

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; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John A Thompson, Ph.D.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 19, 2017
• Study Start: February 27, 2018
• Primary Completion: August 2, 2020
• Study Completion: December 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)