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Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke

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ClinicalTrials.gov Identifier: NCT03344562
Recruitment Status : Terminated (Due to lack of resources (insufficient personnel) and due to technical problems with measurement of primary and secondary outcomes.)
First Posted : November 17, 2017
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Amy Mathews, University of Texas Southwestern Medical Center

Brief Summary:

This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night.

Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes.

The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.


Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Sleep Disorder Device: CES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Stroke
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: CES Active
Active cranial electrical stimulation device
Device: CES
Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep.
Other Name: Fisher-Wallace Cranial Electrical Stimulation

Sham Comparator: CES Sham
Inactive device identical to the active device.
Device: CES
Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
Other Name: Sham cranial electrical stimulation




Primary Outcome Measures :
  1. Hours of Sleep [ Time Frame: 7- 24 hour periods ]
    A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep


Secondary Outcome Measures :
  1. Sleep Efficiency [ Time Frame: 7-24 hour periods ]
    Determined by wrist actigraphy

  2. Karolinska Sleepiness Scale [ Time Frame: Daily for 7 days ]
    Self report for daytime sleepiness with 1 being extremely alert and 10 being extremely sleepy, can't keep awake



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent must be obtained.
  2. Patients must be admitted to inpatient rehab.
  3. Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic).
  4. Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device.
  5. Subjects must Score a 7 or higher on the ISI.
  6. Patients must be able to communicate consent and/or desire to discontinue the study.

Exclusion Criteria 1. Demand or sensing type cardiac pacemaker. 2. Known uncontrolled seizure disorder. 3. Current history of vertigo. 4. Need for continuous O2. 5. Inability to communicate or provide consent. 6. Restricted use or absence of both arms.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344562


Locations
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United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Director: Kathleen R Bell, MD University of Texas
  Study Documents (Full-Text)

Documents provided by Amy Mathews, University of Texas Southwestern Medical Center:
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Responsible Party: Amy Mathews, ASSISTANT PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03344562    
Other Study ID Numbers: STU 072016-005
First Posted: November 17, 2017    Key Record Dates
Results First Posted: December 19, 2020
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Sleep Wake Disorders
Stroke
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases