Trial Outcomes & Findings for Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep (NCT NCT05089682)
NCT ID: NCT05089682
Last Updated: 2023-11-01
Results Overview
Total number of participants to complete all scheduled study activities
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Through study completion, approximately 1 year
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Deep Brain Stimulation (DBS) System
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Deep Brain Stimulation (DBS) System
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Baseline characteristics by cohort
| Measure |
Deep Brain Stimulation (DBS) System
n=4 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Age, Continuous
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37.75 years
STANDARD_DEVIATION 5.25 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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4 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Through study completion, approximately 1 yearTotal number of participants to complete all scheduled study activities
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=4 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Participants to Complete Study
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2 Participants
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SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 1 night)Length of sleep time reported in minutes
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Total Sleep Time
Low Frequency Stimulation (2 Hz - 40 Hz)
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432.5 minutes
Standard Deviation 43.14
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Total Sleep Time
Baseline
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497 minutes
Standard Deviation 38.18
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Total Sleep Time
High Frequency Stimulation (40 Hz - 250 Hz)
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490 minutes
Standard Deviation 26.87
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SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Psychomotor Vigilance Test
Baseline
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388.20 milliseconds
Standard Deviation 50.12
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Psychomotor Vigilance Test
High Frequency Stimulation (40 Hz - 250 Hz)
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422.83 milliseconds
Standard Deviation 72.61
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Psychomotor Vigilance Test
Low Frequency Stimulation (2 Hz - 40 Hz)
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392.72 milliseconds
Standard Deviation 44.22
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Karolinska Sleepiness Scale
Baseline
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3.83 score on a scale
Standard Deviation 1.60
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Karolinska Sleepiness Scale
High Frequency Stimulation (40 Hz - 250 Hz)
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3.67 score on a scale
Standard Deviation 1.21
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Karolinska Sleepiness Scale
Low Frequency Stimulation (2 Hz - 40 Hz)
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4.17 score on a scale
Standard Deviation 1.60
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SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 1 night)Time in minutes from beginning of study to the first stage of sleep
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Latency to Sleep Onset
Baseline
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19 minutes
Standard Deviation 14.14
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Latency to Sleep Onset
High Frequency Stimulation (40 Hz - 250 Hz)
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14 minutes
Standard Deviation 0
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Latency to Sleep Onset
Low Frequency Stimulation (2 Hz - 40 Hz)
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9.5 minutes
Standard Deviation 10.61
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SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 1 night)Time in minutes from beginning of sleep to first REM sleep onset.
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Latency to Rapid Eye Movement (REM) Sleep
High Frequency Stimulation (40 Hz - 250 Hz)
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114.5 minutes
Standard Deviation 58.69
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Latency to Rapid Eye Movement (REM) Sleep
Baseline
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149 minutes
Standard Deviation 86.27
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Latency to Rapid Eye Movement (REM) Sleep
Low Frequency Stimulation (2 Hz - 40 Hz)
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76.5 minutes
Standard Deviation 47.38
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Number of Sleep Cycles
Low Frequency Stimulation (2 Hz - 40 Hz)
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4 number of sleep cycles
Standard Deviation 1.41
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Number of Sleep Cycles
Baseline
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4 number of sleep cycles
Standard Deviation 2.83
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Number of Sleep Cycles
High Frequency Stimulation (40 Hz - 250 Hz)
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4 number of sleep cycles
Standard Deviation 1.41
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SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 1 night)Total number of awakenings during night
Outcome measures
| Measure |
Deep Brain Stimulation (DBS) System
n=2 Participants
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.
DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation.
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Number of Awakenings Per Night
Baseline
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28.5 number of awakenings
Standard Deviation 2.12
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Number of Awakenings Per Night
High Frequency Stimulation (40 Hz - 250 Hz)
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27 number of awakenings
Standard Deviation 1.41
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Number of Awakenings Per Night
Low Frequency Stimulation (2 Hz - 40 Hz)
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20 number of awakenings
Standard Deviation 1.41
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Adverse Events
Deep Brain Stimulation (DBS) System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place