Dyssomnia, Parkinson's Disease and Parkinsonism
Conditions
Keywords
Deep Brain Stimulation, Polysomnography, Sleep Disorders
Brief summary
Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep). For this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.
Detailed description
This prospective study will use the Percept sensing tools, collectively referred to as Brainsense, to correlate STN and GPi-LFP activity to sleep stages, characterize sleep events and evaluate the effects of DBS stimulation on sleep quality and sleep events. This study may help identify and validate novel biomarkers to assess sleep quality, REM behavior disorder,sleep fragmentation, and awakenings in patients with Parkinson's Disease, which will support overall DBS' efficacy beyond motor symptoms, and supplement interventions to improve sleep, and potentially also guide more effective DBS programming.
Interventions
DEVICEPolysomnography ON stimulation then OFF
Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "ON" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
DEVICEPolysomnography OFF stimulation then ON
Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "OFF" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
The subject will be randomized after completion of the baseline visit. This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed to the patient only.
Intervention model description
This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Males and females; Age 40-80 3. Subjects with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device to subthalamic nucleus (STN) or Globus pallidus internus (GPi). 4. Willingness to adhere to the PSG regimen and turn DBS off for one night. 5. A score of ≥23 on the Montreal Cognitive Assessment (MoCA) 6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.
Exclusion criteria
1. History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA). 2. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy. 3. History of Dementia. 4. Report dopaminergic medication changes in the past month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensing & Sleep: Parkinson's Disease Sleep Assessment | Day 1 to Day 14 | A 7 item to rate sleep experience scored 0=unsure, 1=No and 2=Yes. Total range of scores is from 0-14 with a higher score indicating more issues with sleep |
| Motor severity | Baseline to Day 14 | Motor severity will be assessed by the Movement Disorders Society - Unified Parkinson's Disease Rating Scale - part III. This scale is the gold standard for measuring the severity and progression of PD. Part III entails motor examination which consists of 18 questions that are scored on a 0-4 scale. Higher scores suggest greater severity and progressing disease. |
| Epworth Sleepiness Scale (ESS) | Baseline to Day 14 | The ESS is a short, self-administered survey that asks respondents to rate their likelihood of dozing off in eight different situations on a scale of 0-3. The total score ranges from 0-24, and is used to estimate if the respondent has excessive daytime sleepiness that may require medical attention. A score over 10 is abnormal. Higher scores suggest greater severity of daytime sleepiness. |
Countries
United States
Contacts
CONTACTEleni O Vaou, MD
CONTACTOmalys Biggs Rodriguez
PRINCIPAL_INVESTIGATOREleni O Vaou, MD
The University of Texas Health Science Center at San Antonio
PRINCIPAL_INVESTIGATORPablo Coss, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed