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NCT03344562 · ClinicalTrials.gov registry record · NA
Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT03344562 is a NA study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 19 participants.
The verdict
NCT03344562, a NA study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- DEVICE CES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03344562
The ClinicalTrials.gov registry entry for NCT03344562 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CES is the first listed.
NCT03344562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03344562 about?
NCT03344562 is a clinical study titled "Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke". 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 (C...
What is the current status of trial NCT03344562?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2017-02-21. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03344562?
The interventions under investigation include: CES (DEVICE).
Who is sponsoring clinical trial NCT03344562?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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