Cerebrovascular AccidentNCT03344562
Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke
A study testing CES in people with Cerebrovascular Accident and Sleep Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Sleep Disorder
- What is being tested?
- CES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 31 Dec 2019
- 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
- Written informed consent must be obtained.
- Patients must be admitted to inpatient rehab.
- Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic).
- Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device.
- Subjects must Score a 7 or higher on the ISI.
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zale Lipshy University Hospital
Dallas, Texas, 75390
About this study
Official title: Cranial Electrical Stimulation (CES) as Treatment for Insomnia in 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 (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.
Read the detailed description
The purpose of this study is to determine if CES is a reasonable first line alternative to the current standard of care (SOC) which relies on the use of trazodone for patients with subacute stroke. This objective will be answered by addressing the following:
- Specific Aim 1: To determine if stroke patients with insomnia who receive CES treatment sleep more hours than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will accumulate more sleeping hours than patients who are treated with sham CES.
- Specific Aim 2: To determine if stroke patients with insomnia who receive CES treatment have better sleep efficiency than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will demonstrate significantly better sleep efficiency than stroke patients treated with shame CES.
The study will take place at Zale Lipshy Hospital in Dallas, Texas. The study will enroll 85 stroke patients who score 7 or higher on the Insomnia Severity Scale. Patients will be randomized to a control group or CES treatment group. Patients will receive CES or sham CES for 7 days after a 24-hour washout period. Objective and subjective sleep assessments will be conducted daily during the 7-day study period. Endpoints will be total time spent sleeping, sleep efficiency and daytime drowsiness.
The known risks of CES are minimal and mild in nature. They include potential for headache, irritation at the site of electrode placement and dizziness. These adverse reactions are rare and in most cases there are no immediate or delayed side effects.
This randomized controlled trial is designed to meet two study objectives related to quality of sleep and daytime drowsiness.
Demographic data will be collected from the hospital record and will include age, gender, type of stroke, self-reported history of insomnia or other sleep disorder, prior use of sleep medications, in-hospital use of sleep medications, co-morbid medical conditions.
Patients admitted to inpatient rehabilitation (IPR) who consent to the study will undergo an overnight washout period before initiation of CES or sham treatment. This allows for any sleep medication they might have received while in acute care to be metabolized and leave their system. On their admission day, day 0 (d0) patients will be asked if they want to participate in our study. If they choose to participate and meet medical inclusion criteria, they will be tested with ISI. Patients who meet the full criteria will not receive sleep medication or CES on their first night.
The study will begin on day 1 (d1) with the patient receiving 20 minutes of CES/sCES in the morning. This time will be distraction free without the entrance of laboratory technicians, nurses, housekeeping or other staff members. When this period is complete, they will participate in usual care. At midday they will be asked to complete the Karolinska Sleepiness Scale (KSS). The patient will wear the actigraph throughout the study. This procedure will be repeated for 7 treatment days. All procedures will be carried out by research team members or a trained nurse.
The intensity of the CES will begin on setting 2, standard setting recommended by the device manufacturer, and the patient will have the option to increase the intensity to setting 3 on the second treatment day if they feel they did not receive any benefit from the device.
If the patient does not feel they are getting adequate sleep the patient may choose to opt out of CES/sCES treatment and receive the standard of care medication for the remainder of the study. Patients who choose the SOC rescue will continue to be monitored with the actigraph. A patient may choose to leave the study at any time.
Information on side effects for the CES treatment will be collected during the 7 days of the study.
Methods of assigning patients to treatment groups and blinding Patients will be randomized to the active or sham treatment group using an online randomizer, Research randomizer (www.randomizer.org). A list of random numbers will be generated prior to the study. Patients will be assigned a random number in the order that the generator produces. All even patients will be assigned to the control group; odd numbered patients will be assigned to the treatment group.
Procedural responsibilities and oversight Nursing staff will be educated how to administer the CES and asked to help distribute and collect the Karolinska Sleepiness Scale questionnaire. Photos of proper placement and instructions will be posted in subjects' rooms for reference. Researchers affiliated with this project will apply and remove the actigraph watches and be responsible for data acquisition, cleaning and charging of the devices. Researchers affiliated with the study will be responsible for ensuring CES is delivered to the appropriate patients on the days required per protocol.
Verbal recruitment process will be used for the study. The attending and resident physicians will be educated about the study and asked to identity patients who may be appropriate. A member of the research team will explain the risks, benefits and rationale for the study to patients who meet inclusion criteria. Patients will be enrolled when they arrive on the rehabilitation floor if they choose to participate. Consent will be attained via a written document in the subject's primary language (English or Spanish).
The research team will protect subjects' privacy by conducting all study related verbal interactions with the subject in a closed room, such as the patient's room. For confidentiality, each subject screened will be assigned a unique identification number (ID#). Subjects will only be identified by the unique ID # in the data. No demographic data or personal information will be used to identify subjects. This unique ID# will be linked to subject name and will be kept in a locked file cabinet, accessible only to the research team. Only the research team will have access to the data. All data for presentations and publications will be reported as mean ± standard error of means. Investigators will educate faculty and residents on each floor about the study to maintain privacy and compliance.
Sample size was calculated based on several studies that measured the number of hours that subacute rehabilitation patients sleep in an inpatient hospital setting. Alpha levels for error probability were set at .05 for a two-tailed test with 80% power to detect a difference between means of control group compared to CES treatment group.
Descriptive statistics will be used to determine differences between CES and sCES treatment groups. A T-test will be used to determine if sleep time means differ between groups (p≤ .05). A chi square analysis will be used to compare data collected from the Karolinska Sleepiness Scale. A non-parametric test will be used if data is not able to demonstrate normal distribution.
- Conditions
- Cerebrovascular Accident, Sleep Disorder
- Being tested
- CES
- Medical subject headings
- Stroke, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CESDevice
Also called Fisher-Wallace Cranial Electrical Stimulation
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.
CESDevice
Also called Sham cranial electrical stimulation
Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| CES Active | Experimental | Active cranial electrical stimulation device Receives: Device: CES |
| CES Sham | Sham comparator | Inactive device identical to the active device. Receives: Device: CES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours of Sleep
A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep
Measured: 7- 24 hour periods
Secondary outcomes (2)
Sleep Efficiency
Determined by wrist actigraphy
Measured: 7-24 hour periods
Karolinska Sleepiness Scale
Self report for daytime sleepiness with 1 being extremely alert and 10 being extremely sleepy, can't keep awake
Measured: Daily for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start21 Feb 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Due to lack of resources (insufficient personnel) and due to technical problems with measurement of primary and secondary outcomes.
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 Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Mathews, University of Texas Southwestern Medical Center
- Investigators
- Kathleen R Bell, MD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344562
- Sponsor's protocol ID
- STU 072016-005
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2017
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Stroke
- ClinicalTrials.gov ID
- NCT03344562
- Acronym / sponsor ID
- STU 072016-005
- Conditions
- Cerebrovascular Accident, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of resources (insufficient personnel) and due to technical problems with measurement of primary and secondary outcomes.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine if CES is a reasonable first line alternative to the current standard of care (SOC) which relies on the use of trazodone for patients with subacute stroke. This objective will be answered by addressing the following:
- Specific Aim 1: To determine if stroke patients with insomnia who receive CES treatment sleep more hours than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will accumulate more sleeping hours than patients who are treated with sham CES.
- Specific Aim 2: To determine if stroke patients with insomnia who receive CES treatment have better sleep efficiency than stroke patients treated with sham CES.
Hypothesis: Stroke patients with insomnia who are treated with CES will demonstrate significantly better sleep efficiency than stroke patients treated with shame CES.
The study will take place at Zale Lipshy Hospital in Dallas, Texas. The study will enroll 85 stroke patients who score 7 or higher on the Insomnia Severity Scale. Patients will be randomized to a control group or CES treatment group. Patients will receive CES or sham CES for 7 days after a 24-hour washout period. Objective and subjective sleep assessments will be conducted daily during the 7-day study period. Endpoints will be total time spent sleeping, sleep efficiency and daytime drowsiness.
The known risks of CES are minimal and mild in nature. They include potential for headache, irritation at the site of electrode placement and dizziness. These adverse reactions are rare and in most cases there are no immediate or delayed side effects.
This randomized controlled trial is designed to meet two study objectives related to quality of sleep and daytime drowsiness.
Demographic data will be collected from the hospital record and will include age, gender, type of stroke, self-reported history of insomnia or other sleep disorder, prior use of sleep medications, in-hospital use of sleep medications, co-morbid medical conditions.
Patients admitted to inpatient rehabilitation (IPR) who consent to the study will undergo an overnight washout period before initiation of CES or sham treatment. This allows for any sleep medication they might have received while in acute care to be metabolized and leave their system. On their admission day, day 0 (d0) patients will be asked if they want to participate in our study. If they choose to participate and meet medical inclusion criteria, they will be tested with ISI. Patients who meet the full criteria will not receive sleep medication or CES on their first night.
The study will begin on day 1 (d1) with the patient receiving 20 minutes of CES/sCES in the morning. This time will be distraction free without the entrance of laboratory technicians, nurses, housekeeping or other staff members. When this period is complete, they will participate in usual care. At midday they will be asked to complete the Karolinska Sleepiness Scale (KSS). The patient will wear the actigraph throughout the study. This procedure will be repeated for 7 treatment days. All procedures will be carried out by research team members or a trained nurse.
The intensity of the CES will begin on setting 2, standard setting recommended by the device manufacturer, and the patient will have the option to increase the intensity to setting 3 on the second treatment day if they feel they did not receive any benefit from the device.
If the patient does not feel they are getting adequate sleep the patient may choose to opt out of CES/sCES treatment and receive the standard of care medication for the remainder of the study. Patients who choose the SOC rescue will continue to be monitored with the actigraph. A patient may choose to leave the study at any time.
Information on side effects for the CES treatment will be collected during the 7 days of the study.
Methods of assigning patients to treatment groups and blinding Patients will be randomized to the active or sham treatment group using an online randomizer, Research randomizer (www.randomizer.org). A list of random numbers will be generated prior to the study. Patients will be assigned a random number in the order that the generator produces. All even patients will be assigned to the control group; odd numbered patients will be assigned to the treatment group.
Procedural responsibilities and oversight Nursing staff will be educated how to administer the CES and asked to help distribute and collect the Karolinska Sleepiness Scale questionnaire. Photos of proper placement and instructions will be posted in subjects' rooms for reference. Researchers affiliated with this project will apply and remove the actigraph watches and be responsible for data acquisition, cleaning and charging of the devices. Researchers affiliated with the study will be responsible for ensuring CES is delivered to the appropriate patients on the days required per protocol.
Verbal recruitment process will be used for the study. The attending and resident physicians will be educated about the study and asked to identity patients who may be appropriate. A member of the research team will explain the risks, benefits and rationale for the study to patients who meet inclusion criteria. Patients will be enrolled when they arrive on the rehabilitation floor if they choose to participate. Consent will be attained via a written document in the subject's primary language (English or Spanish).
The research team will protect subjects' privacy by conducting all study related verbal interactions with the subject in a closed room, such as the patient's room. For confidentiality, each subject screened will be assigned a unique identification number (ID#). Subjects will only be identified by the unique ID # in the data. No demographic data or personal information will be used to identify subjects. This unique ID# will be linked to subject name and will be kept in a locked file cabinet, accessible only to the research team. Only the research team will have access to the data. All data for presentations and publications will be reported as mean ± standard error of means. Investigators will educate faculty and residents on each floor about the study to maintain privacy and compliance.
Sample size was calculated based on several studies that measured the number of hours that subacute rehabilitation patients sleep in an inpatient hospital setting. Alpha levels for error probability were set at .05 for a two-tailed test with 80% power to detect a difference between means of control group compared to CES treatment group.
Descriptive statistics will be used to determine differences between CES and sCES treatment groups. A T-test will be used to determine if sleep time means differ between groups (p≤ .05). A chi square analysis will be used to compare data collected from the Karolinska Sleepiness Scale. A non-parametric test will be used if data is not able to demonstrate normal distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CES Active | Experimental | Device: CESActive cranial electrical stimulation device |
| CES Sham | Sham comparator | Device: CESInactive device identical to the active device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent must be obtained.
- Patients must be admitted to inpatient rehab.
- Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic).
- Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device.
- Subjects must Score a 7 or higher on the ISI.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CESAlso: Fisher-Wallace Cranial Electrical StimulationPatients 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 Active |
| CESAlso: Sham cranial electrical stimulationPatient will receive sham electrical stimulation once a day for 20 minutes over 7 days. | Device | CES Sham |
Primary outcome
Hours of Sleep
Time frame: 7- 24 hour periods
A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep
2 secondary outcomes
Sleep Efficiency
Time frame: 7-24 hour periods
Karolinska Sleepiness Scale
Time frame: Daily for 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kathleen R Bell, MD study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CES in people with Cerebrovascular Accident and Sleep Disorder, run by University of Texas Southwestern Medical Center 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 8 inclusion and 0 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 19 Dec 2020. 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. Some participants in this study may receive a placebo. 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 19 Dec 2020). 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?
Hours of Sleep (time frame: 7- 24 hour periods). 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 19 Dec 2020.