Trial Outcomes & Findings for Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery (NCT NCT03735004)
NCT ID: NCT03735004
Last Updated: 2026-06-22
Results Overview
IV morphine milligram equivalents
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery room
Results posted on
2026-06-22
Participant Flow
Participant milestones
| Measure |
TES 60 Hz DC:AC
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
TES 100 Hz DC:AC
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
Transcranial electrostimulation (TES) with direct current (DC) only
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 12.3 • n=15 Participants
|
41.5 years
STANDARD_DEVIATION 11.5 • n=15 Participants
|
46.7 years
STANDARD_DEVIATION 10.3 • n=15 Participants
|
46.3 years
STANDARD_DEVIATION 11.7 • n=45 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
9 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
36 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
45 Participants
n=45 Participants
|
|
Height
|
170.5 cm
STANDARD_DEVIATION 10.5 • n=15 Participants
|
176.3 cm
STANDARD_DEVIATION 10.4 • n=15 Participants
|
178.7 cm
STANDARD_DEVIATION 8.6 • n=15 Participants
|
175.2 cm
STANDARD_DEVIATION 10.3 • n=45 Participants
|
|
Weight
|
92.3 kg
STANDARD_DEVIATION 17.1 • n=15 Participants
|
92.5 kg
STANDARD_DEVIATION 19.9 • n=15 Participants
|
97.7 kg
STANDARD_DEVIATION 14.9 • n=15 Participants
|
94.2 kg
STANDARD_DEVIATION 17.2 • n=45 Participants
|
|
Body Mass Index (BMI)
|
31.4 kg/m^2
STANDARD_DEVIATION 5.4 • n=15 Participants
|
30.0 kg/m^2
STANDARD_DEVIATION 7.0 • n=15 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=15 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=45 Participants
|
|
American Society of Anesthesiologists (ASA) class
Class 1
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
American Society of Anesthesiologists (ASA) class
Class 2
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
13 Participants
n=45 Participants
|
|
American Society of Anesthesiologists (ASA) class
Class 3
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
32 Participants
n=45 Participants
|
|
Apnea-Hypopnea Index
|
48.3 events per hour
STANDARD_DEVIATION 23.4 • n=15 Participants
|
42.1 events per hour
STANDARD_DEVIATION 20.3 • n=15 Participants
|
46.7 events per hour
STANDARD_DEVIATION 28.6 • n=15 Participants
|
45.7 events per hour
STANDARD_DEVIATION 23.9 • n=45 Participants
|
PRIMARY outcome
Timeframe: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery roomIV morphine milligram equivalents
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Opioid Requirements During First Postoperative TES Session
|
6.9 IV morphine milligram equivalents
Standard Deviation 5.5
|
9.8 IV morphine milligram equivalents
Standard Deviation 3.8
|
3.3 IV morphine milligram equivalents
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Recorded during a 20 min TES session administered for first moderate-to-severe postoperative pain in the recovery roomPopulation: Participants with available data
VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=14 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Pain Scores During First Postoperative TES Session
|
7.2 score on a scale
Standard Deviation 1.6
|
7.8 score on a scale
Standard Deviation 1.5
|
6.6 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: During the recovery room stay until "floor ready" (on average 2.5 hours)IV morphine milligram equivalents
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Postoperative Opioid Consumption During Recovery Room Stay
|
19.10 IV morphine milligram equivalents
Standard Deviation 12.97
|
25.22 IV morphine milligram equivalents
Standard Deviation 11.71
|
10.62 IV morphine milligram equivalents
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: During the recovery room stay until "floor ready" (on average 2.5 hours)VAS pain scores (Pain measured using 11-point visual analog scale 0-10, 0 no pain, 10 worst pain imaginable).
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Postoperative Pain Scores During Recovery Room Stay
|
5.8 score on a scale
Standard Deviation 1.5
|
6.5 score on a scale
Standard Deviation 1.3
|
5.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: From "floor ready" until midnight of the day after surgery (POD#0, (postoperative day #0).PO morphine milligram equivalents
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Postoperative Opioid Consumption During Post-operative Day 0
|
19.9 oral morphine milligram equivalents
Standard Deviation 17.9
|
25.1 oral morphine milligram equivalents
Standard Deviation 12.0
|
27.1 oral morphine milligram equivalents
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: From POD#1 through the 1st postoperative week after surgery.Population: Participants with available data
PO morphine milligram equivalents
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=14 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Post-discharge Postoperative Opioid Consumption
|
249.0 oral morphine milligram equivalents
Standard Deviation 237.8
|
343.1 oral morphine milligram equivalents
Standard Deviation 154.2
|
250 oral morphine milligram equivalents
Standard Deviation 138.3
|
SECONDARY outcome
Timeframe: Day of surgery (postoperative day #0, POD#0).Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=15 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Time to Discharge From the Recovery Room
|
129.3 minutes
Interval 105.4 to 155.9
|
133.2 minutes
Interval 108.7 to 156.9
|
82.7 minutes
Interval 72.5 to 94.1
|
SECONDARY outcome
Timeframe: Day of surgery to starting a soft diet (up to 7 days postoperative)Population: Participants with available data
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=12 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=14 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Time to Start of Soft Diet
|
4.7 days
Standard Deviation 4.5
|
5.1 days
Standard Deviation 5.2
|
3.5 days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Day of surgery to return to daily activities to postoperative week 4.Population: Participants with available data
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=10 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=14 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Time to Return to Daily Activities
|
13 days
Standard Deviation 4.6
|
12.9 days
Standard Deviation 6.7
|
11.2 days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: From the day of surgery to return to work to postoperative week 4.Population: Participants with available data
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=13 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=14 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=14 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Time to Return to Work
|
18.5 days
Standard Deviation 7.9
|
18.6 days
Standard Deviation 8.6
|
16.5 days
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline (before surgery) to postoperative week 4.Population: Participants with available data
Validated multidimensional questionnaire assessing recovery profile. Each scale is scored from 0-10, overall score from 0 to 150. The higher scores indicate better recovery.
Outcome measures
| Measure |
TES 100 Hz DC:AC
n=15 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 100 Hz) current
|
TES With DC Current
n=14 Participants
Transcranial electrostimulation (TES) with direct current (DC) only
|
TES 60 Hz DC:AC
n=14 Participants
Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC, 60 Hz) current
|
|---|---|---|---|
|
Change From Baseline in QoR15 Score (Quality of Recovery 15-question Score)
|
-31.0 score on a scale
Interval -60.0 to -25.0
|
-50.5 score on a scale
Interval -55.0 to -40.0
|
-36.5 score on a scale
Interval -58.25 to -19.75
|
Adverse Events
TES 60 Hz DC:AC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TES 100 Hz DC:AC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TES With DC Current
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place