Trial Outcomes & Findings for Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep (NCT NCT03050372)
NCT ID: NCT03050372
Last Updated: 2020-02-13
Results Overview
SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and \>20min is considered to be associated with no sleep debt.
TERMINATED
NA
12 participants
Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
2020-02-13
Participant Flow
Eligibility screening was completed over the phone by trained sleep personnel; sleep laboratory is located at the Medical University of South Carolina's Institute of Psychiatry at 67 President St., Charleston S.C. This is a crossover study; each participant is exposed to both active and sham conditions.
N=209 subjects screened from 07/2016-07/2017; N=193 participants were excluded prior to PSG because they declined to participate (N=49), did not meet the age criterion (N=28), did not meet the sleep criterion (N=61), had co-morbid psychiatric disorders (N=42), or for other reasons (N=13); N=4 excluded after consent due to medication/baby/no-show.
Participant milestones
| Measure |
Active Low Field Magnetic Stimulation (LFMS), Then Sham LFMS
Adaptation Night; then two consecutive nights of Active LFMS; after washout two consecutive nights of Sham LFMS
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
|
Sham Low Field Magnetic Stimulation (LFMS), Then Active LFMS
Adaptation Night; then two consecutive nights of Sham LFMS; after washout followed by two consecutive nights of Active LFMS
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
|
|---|---|---|
|
Adaptation Night (Night #1 PSG)
STARTED
|
6
|
6
|
|
Adaptation Night (Night #1 PSG)
COMPLETED
|
5
|
6
|
|
Adaptation Night (Night #1 PSG)
NOT COMPLETED
|
1
|
0
|
|
First Intervention (Nights #2 and #3)
STARTED
|
5
|
6
|
|
First Intervention (Nights #2 and #3)
COMPLETED
|
5
|
6
|
|
First Intervention (Nights #2 and #3)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Nights #4 and #5)
STARTED
|
5
|
6
|
|
Second Intervention (Nights #4 and #5)
COMPLETED
|
5
|
5
|
|
Second Intervention (Nights #4 and #5)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Low Field Magnetic Stimulation (LFMS), Then Sham LFMS
Adaptation Night; then two consecutive nights of Active LFMS; after washout two consecutive nights of Sham LFMS
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
|
Sham Low Field Magnetic Stimulation (LFMS), Then Active LFMS
Adaptation Night; then two consecutive nights of Sham LFMS; after washout followed by two consecutive nights of Active LFMS
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab
|
|---|---|---|
|
Adaptation Night (Night #1 PSG)
Adverse Event
|
1
|
0
|
|
Second Intervention (Nights #4 and #5)
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
Participants are randomized to receive either two consecutive nights of "Active Low Field Magnetic Stimulation" followed by "Sham Low Field Magnetic Stimulation" or vice versa.
Active Low Field Magnetic Stimulation LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
Sham Low Field Magnetic Stimulation LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|
|
Age, Continuous
|
35.58 years
STANDARD_DEVIATION 8.512 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Height
|
67.83 inch
STANDARD_DEVIATION 3.54 • n=5 Participants
|
|
Weight
|
184.83 lbm (pound mass)
STANDARD_DEVIATION 35.70 • n=5 Participants
|
|
PSQI (Pittsburgh Sleep Quality Inventory)
|
11.58 units on a scale
STANDARD_DEVIATION 2.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and \>20min is considered to be associated with no sleep debt.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline SOL
|
43.35 minutes
Standard Deviation 25.95
|
43.35 minutes
Standard Deviation 25.95
|
|
Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Intervention LFMS; two-night average in each arm
|
53.88 minutes
Standard Deviation 40.03
|
46.35 minutes
Standard Deviation 34.50
|
|
Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline SOL
|
10.53 minutes
Standard Deviation 31.67
|
3.00 minutes
Standard Deviation 22.77
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Total time awake after initial sleep onset in minutes; validated objective measure directly extracted from polysomnography (PSG); we average measures from both consecutive nights under each of the two interventions (Sham or Active LFMS)
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline WASO
|
80.85 minutes
Standard Deviation 78.41
|
80.85 minutes
Standard Deviation 78.41
|
|
Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
54.80 minutes
Standard Deviation 46.87
|
56.00 minutes
Standard Deviation 31.31
|
|
Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline WASO
|
26.05 minutes
Standard Deviation 41.69
|
24.85 minutes
Standard Deviation 59.75
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline TST
|
359.60 minutes
Standard Deviation 86.60
|
359.60 minutes
Standard Deviation 86.60
|
|
Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
370.40 minutes
Standard Deviation 80.96
|
388.53 minutes
Standard Deviation 73.02
|
|
Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline TST
|
10.80 minutes
Standard Deviation 60.50
|
28.93 minutes
Standard Deviation 82.73
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Sleep Efficiency (SE) is an objective measure of sleep quality derived from polysomnography (PSG); it is a unitless measure defined as the total sleep time (TST) divided by total time in bed (TiB); it can theoretically range from 0 (no sleep at all) to 1 (slept the entire time in bed). Values close to zero indicate very little time spent sleeping while values close to one indicate a large sleep utilization while in bed.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline SE
|
0.72 unitless ratio (0 to 1)
Standard Deviation 0.16
|
0.72 unitless ratio (0 to 1)
Standard Deviation 0.16
|
|
Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
0.77 unitless ratio (0 to 1)
Standard Deviation 0.11
|
0.79 unitless ratio (0 to 1)
Standard Deviation 0.08
|
|
Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline SE
|
0.05 unitless ratio (0 to 1)
Standard Deviation 0.11
|
0.07 unitless ratio (0 to 1)
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Ease of Sleep (EOS) is assessed after each night as a subjective measure; participants self-rate their ease to fall asleep on a visual analog scale 0-100mm where 0mm is associated with not easy at all (no sleep) and 100mm is associated with no problems to fall asleep. EOS is a proxy measure for a participants sleepiness.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline EOS
|
63.30 units on a scale (0-100mm)
Standard Deviation 30.99
|
63.30 units on a scale (0-100mm)
Standard Deviation 30.99
|
|
Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
51.95 units on a scale (0-100mm)
Standard Deviation 26.47
|
47.70 units on a scale (0-100mm)
Standard Deviation 17.76
|
|
Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline EOS
|
-11.35 units on a scale (0-100mm)
Standard Deviation 25.70
|
-15.60 units on a scale (0-100mm)
Standard Deviation 26.17
|
PRIMARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
MUSC Sleep Quality Score (SQS) is assessed after each night as a subjective measure; participants self-rate their perceived sleep quality on a 0-6 scale where 0 is associated with extremely poor sleep quality and 6 is associated with extremely good sleep quality.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline SQS
|
1.90 score on a scale (0-6)
Standard Deviation 0.74
|
1.90 score on a scale (0-6)
Standard Deviation 0.74
|
|
MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
2.75 score on a scale (0-6)
Standard Deviation 0.82
|
2.75 score on a scale (0-6)
Standard Deviation 1.25
|
|
MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline SQS
|
0.85 score on a scale (0-6)
Standard Deviation 0.71
|
0.85 score on a scale (0-6)
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline #awake
|
19 awakenings
Standard Deviation 8.31
|
19 awakenings
Standard Deviation 8.31
|
|
Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
17.45 awakenings
Standard Deviation 5.36
|
21.17 awakenings
Standard Deviation 8.31
|
|
Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline #awake
|
-1.55 awakenings
Standard Deviation 5.30
|
2.50 awakenings
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline fatigue
|
58.10 units on a scale (0-100mm)
Standard Deviation 24.73
|
58.10 units on a scale (0-100mm)
Standard Deviation 24.73
|
|
Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
52.65 units on a scale (0-100mm)
Standard Deviation 22.30
|
45.45 units on a scale (0-100mm)
Standard Deviation 27.58
|
|
Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline fatigue
|
-5.45 units on a scale (0-100mm)
Standard Deviation 11.13
|
-12.65 units on a scale (0-100mm)
Standard Deviation 23.90
|
SECONDARY outcome
Timeframe: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMSPopulation: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
Participants rate after each night their ability to concentrate on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. This is a subjective proxy measure for a restorative sleep / sleep quality.
Outcome measures
| Measure |
Active Low Field Magnetic Stimulation
n=10 Participants
LFMS - Active
LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
|
Sham Low Field Magnetic Stimulation
n=10 Participants
LFMS - Sham
LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
|
|---|---|---|
|
Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Baseline concentration
|
46.80 units on a scale (0-100mm)
Standard Deviation 22.42
|
46.80 units on a scale (0-100mm)
Standard Deviation 22.42
|
|
Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sham or Active LFMS (two-night average)
|
42.40 units on a scale (0-100mm)
Standard Deviation 19.58
|
36.80 units on a scale (0-100mm)
Standard Deviation 20.37
|
|
Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Change from Baseline concentration
|
-4.40 units on a scale (0-100mm)
Standard Deviation 11.28
|
-10.00 units on a scale (0-100mm)
Standard Deviation 18.09
|
Adverse Events
Entire Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas W. Uhde, M.D.
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place