Neurological DiseaseNCT05089682
Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
A study testing DBS Stimulation during sleep in people with Neurological Disease and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disease, Parkinson Disease, Epilepsy
- What is being tested?
- DBS Stimulation during sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Neurological Disease, Parkinson Disease, Epilepsy
- Being tested
- DBS Stimulation during sleep
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Nervous System Diseases, Parkinson Disease, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS Stimulation during sleepDevice
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 group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation (DBS) system | Experimental | 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. Receives: Device: DBS Stimulation during sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants to Complete Study
Total number of participants to complete all scheduled study activities
Measured: Through study completion, approximately 1 year
Secondary outcomes (7)
Total Sleep Time
Length of sleep time reported in minutes
Measured: Baseline, post-intervention (approximately 1 night)
Psychomotor Vigilance Test
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).
Measured: Baseline, post-intervention (approximately 1 night)
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.
Measured: Baseline, post-intervention (approximately 1 night)
Latency to Sleep Onset
Time in minutes from beginning of study to the first stage of sleep
Measured: Baseline, post-intervention (approximately 1 night)
Latency to Rapid Eye Movement (REM) Sleep
Time in minutes from beginning of sleep to first REM sleep onset.
Measured: Baseline, post-intervention (approximately 1 night)
Number of Sleep Cycles
Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep.
Measured: Baseline, post-intervention (approximately 1 night)
Number of Awakenings Per Night
Total number of awakenings during night
Measured: Baseline, post-intervention (approximately 1 night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start22 Jun 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Why it stopped: Unable to enroll subjects due to COVID and complexity of study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurological DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Worrell, Mayo Clinic
- Investigators
- Gregory Worrell, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089682
- Sponsor's protocol ID
- 19-001216
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2021
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
- ClinicalTrials.gov ID
- NCT05089682
- Acronym / sponsor ID
- 19-001216
- Conditions
- Neurological Disease, Parkinson Disease, Epilepsy
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll subjects due to COVID and complexity of study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation (DBS) system | Experimental | Device: DBS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS Stimulation during sleepOpen and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation. | Device | Deep Brain Stimulation (DBS) system |
Primary outcome
Participants to Complete Study
Time frame: Through study completion, approximately 1 year
Total number of participants to complete all scheduled study activities
7 secondary outcomes
Total Sleep Time
Time frame: Baseline, post-intervention (approximately 1 night)
Psychomotor Vigilance Test
Time frame: Baseline, post-intervention (approximately 1 night)
Karolinska Sleepiness Scale
Time frame: Baseline, post-intervention (approximately 1 night)
Latency to Sleep Onset
Time frame: Baseline, post-intervention (approximately 1 night)
Latency to Rapid Eye Movement (REM) Sleep
Time frame: Baseline, post-intervention (approximately 1 night)
Number of Sleep Cycles
Time frame: Baseline, post-intervention (approximately 1 night)
Number of Awakenings Per Night
Time frame: Baseline, post-intervention (approximately 1 night)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Worrell, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS Stimulation during sleep in people with Neurological Disease and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants to Complete Study (time frame: Through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.