Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

October 31, 2023 updated by: Gregory Worrell, Mayo Clinic

Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: Baseline, post-intervention (approximately 1 night)
Length of sleep time reported in minutes
Baseline, post-intervention (approximately 1 night)
Psychomotor Vigilance Test
Time Frame: 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).
Baseline, post-intervention (approximately 1 night)
Karolinska Sleepiness Scale
Time Frame: 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.
Baseline, post-intervention (approximately 1 night)
Latency to Sleep Onset
Time Frame: Baseline, post-intervention (approximately 1 night)
Time in minutes from beginning of study to the first stage of sleep
Baseline, post-intervention (approximately 1 night)
Latency to Rapid Eye Movement (REM) Sleep
Time Frame: Baseline, post-intervention (approximately 1 night)
Time in minutes from beginning of sleep to first REM sleep onset.
Baseline, post-intervention (approximately 1 night)
Number of Sleep Cycles
Time Frame: 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.
Baseline, post-intervention (approximately 1 night)
Number of Awakenings Per Night
Time Frame: Baseline, post-intervention (approximately 1 night)
Total number of awakenings during night
Baseline, post-intervention (approximately 1 night)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Gregory Worrell, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Actual)

December 18, 2021

Study Completion (Actual)

December 18, 2021

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-001216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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