Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
- Conditions
- Parkinson DiseaseNeurological DiseaseEpilepsy
- Interventions
- Device: DBS Stimulation during sleep
- Registration Number
- NCT05089682
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- DBS in one of the defined nuclei of interest during the period of the study
- Be willing and able to give written and oral informed consent
- Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight
- All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence.
- Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
- Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate
- Pregnancy test positive.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Deep Brain Stimulation (DBS) system DBS Stimulation during sleep Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device.
- Primary Outcome Measures
Name Time Method Participants to Complete Study Through study completion, approximately 1 year Total number of participants to complete all scheduled study activities
- Secondary Outcome Measures
Name Time Method Latency to Sleep Onset Baseline, post-intervention (approximately 1 night) Time in minutes from beginning of study to the first stage of sleep
Psychomotor Vigilance Test Baseline, post-intervention (approximately 1 night) Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes).
Total Sleep Time Baseline, post-intervention (approximately 1 night) Length of sleep time reported in minutes
Karolinska Sleepiness Scale Baseline, post-intervention (approximately 1 night) Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep.
Latency to Rapid Eye Movement (REM) Sleep Baseline, post-intervention (approximately 1 night) Time in minutes from beginning of sleep to first REM sleep onset.
Number of Awakenings Per Night Baseline, post-intervention (approximately 1 night) Total number of awakenings during night
Number of Sleep Cycles Baseline, post-intervention (approximately 1 night) Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States