Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

Mayo Clinic1 site in 1 country4 target enrollmentJune 22, 2021

ConditionsNeurological Disease Parkinson Disease Epilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurological Disease
Sponsor: Mayo Clinic
Enrollment: 4
Locations: 1
Primary Endpoint: Participants to Complete Study
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 22, 2021

End Date

December 18, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Gregory Worrell

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Participants to Complete Study

Time Frame: Through study completion, approximately 1 year

Total number of participants to complete all scheduled study activities

Secondary Outcomes

Latency to Sleep Onset(Baseline, post-intervention (approximately 1 night))
Psychomotor Vigilance Test(Baseline, post-intervention (approximately 1 night))
Total Sleep Time(Baseline, post-intervention (approximately 1 night))
Karolinska Sleepiness Scale(Baseline, post-intervention (approximately 1 night))
Latency to Rapid Eye Movement (REM) Sleep(Baseline, post-intervention (approximately 1 night))
Number of Awakenings Per Night(Baseline, post-intervention (approximately 1 night))
Number of Sleep Cycles(Baseline, post-intervention (approximately 1 night))