Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05089682

Enrollment

Registered

2021-10-22

Start date

2021-06-22

Completion date

2021-12-18

Last updated

2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Neurological Disease, Parkinson Disease

Keywords

Deep Brain Stimulation

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.

Interventions

DEVICEDBS 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Design outcomes

Primary

Measure	Time frame	Description
Participants to Complete Study	Through study completion, approximately 1 year	Total number of participants to complete all scheduled study activities

Secondary

Measure	Time frame	Description
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).
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 Sleep Onset	Baseline, post-intervention (approximately 1 night)	Time in minutes from beginning of study to the first stage of sleep
Total Sleep Time	Baseline, post-intervention (approximately 1 night)	Length of sleep time reported in minutes
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.
Number of Awakenings Per Night	Baseline, post-intervention (approximately 1 night)	Total number of awakenings during night
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	4
Total	4

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Deep Brain Stimulation (DBS) System
Age, Continuous	37.75 years STANDARD_DEVIATION 5.25
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	4 Participants
Region of Enrollment United States	4 participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 4
other Total, other adverse events	0 / 4
serious Total, serious adverse events	0 / 4

Outcome results

Primary

Participants to Complete Study

Total number of participants to complete all scheduled study activities

Time frame: Through study completion, approximately 1 year

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Deep Brain Stimulation (DBS) System	Participants to Complete Study	2 Participants

Secondary

Karolinska Sleepiness Scale

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.