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

NCT03344562 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-12-19

Study results available
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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.

Conditions

  • Cerebrovascular Accident
  • Sleep Disorder

Interventions

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.

DEVICE

CES

Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Kathleen R Bell, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344562 on ClinicalTrials.gov