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Trial Outcomes & Findings for Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke (NCT NCT03344562)

NCT ID: NCT03344562

Last Updated: 2020-12-19

Results Overview

A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

7- 24 hour periods

Results posted on

2020-12-19

Participant Flow

Participant milestones

Participant milestones
Measure
CES Active
Active cranial electrical stimulation 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.
CES Sham
Inactive device identical to the active device. CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
Overall Study
STARTED
10
9
Overall Study
COMPLETED
8
9
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
CES Active
Active cranial electrical stimulation 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.
CES Sham
Inactive device identical to the active device. CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
Overall Study
Withdrawal by Subject
2
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CES Active
n=10 Participants
Active cranial electrical stimulation 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.
CES Sham
n=9 Participants
Inactive device identical to the active device. CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
Total
n=19 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
8 Participants
n=7 Participants
18 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
9 participants
n=7 Participants
19 participants
n=5 Participants

PRIMARY outcome

Timeframe: 7- 24 hour periods

Population: Data has not been analyzed. Small numbers of subjects due to termination of study. There were also technical problems with measurement of primary and secondary outcomes leading to unreliable or uninterpretable data. Due to lack of resources.

A wrist actigraph will record continuously for 7 days. Primary outcome hours of sleep

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7-24 hour periods

Population: Data has not been analyzed. Small numbers of subjects due to termination of study. There were also technical problems with measurement of primary and secondary outcomes leading to unreliable or uninterpretable data. Due to lack of resources.

Determined by wrist actigraphy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Daily for 7 days

Population: Data has not been analyzed. Small numbers of subjects due to termination of study. There were also technical problems with measurement of primary and secondary outcomes leading to unreliable or uninterpretable data. Due to lack of resources.

Self report for daytime sleepiness with 1 being extremely alert and 10 being extremely sleepy, can't keep awake

Outcome measures

Outcome data not reported

Adverse Events

CES Active

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

CES Sham

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
CES Active
n=10 participants at risk
Active cranial electrical stimulation 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.
CES Sham
n=9 participants at risk
Inactive device identical to the active device. CES: Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
Nervous system disorders
Headache
10.0%
1/10 • Number of events 1 • Adverse event data were collected from baseline up to 1 week during their treatment period.
0.00%
0/9 • Adverse event data were collected from baseline up to 1 week during their treatment period.

Additional Information

Dr. Amy Mathews - ASSISTANT PROFESSOR

University of Texas Southwestern Medical Center

Phone: 214/645-1719

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place