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Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Not Applicable
Terminated
Conditions
Parkinson Disease
Neurological Disease
Epilepsy
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
Inclusion Criteria
  • 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.
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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Deep Brain Stimulation (DBS) systemDBS Stimulation during sleepSubjects 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
NameTimeMethod
Participants to Complete StudyThrough study completion, approximately 1 year

Total number of participants to complete all scheduled study activities

Secondary Outcome Measures
NameTimeMethod
Latency to Sleep OnsetBaseline, post-intervention (approximately 1 night)

Time in minutes from beginning of study to the first stage of sleep

Psychomotor Vigilance TestBaseline, 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 TimeBaseline, post-intervention (approximately 1 night)

Length of sleep time reported in minutes

Karolinska Sleepiness ScaleBaseline, 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) SleepBaseline, post-intervention (approximately 1 night)

Time in minutes from beginning of sleep to first REM sleep onset.

Number of Awakenings Per NightBaseline, post-intervention (approximately 1 night)

Total number of awakenings during night

Number of Sleep CyclesBaseline, 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

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