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Funding no longer available
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| Name | Class |
|---|---|
| Tal Medical, Inc. | INDUSTRY |
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Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Low Field Magnetic Stimulation | Experimental | LFMS - Active |
|
| Sham Low Field Magnetic Stimulation | Sham Comparator | LFMS - Sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFMS - Active | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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 |
| Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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) | 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 |
| Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG). | 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 |
| Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Uhde, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
This process is still being discussed by investigators. Once plan is complete it will likely include protocol and primary outcome measures which may be accessed through peer reviewed publications.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adaptation Night (Night #1 PSG) |
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| First Intervention (Nights #2 and #3) |
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| Second Intervention (Nights #4 and #5) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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. | Posted | Mean | Standard Deviation | minutes | 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 |
|
Beginning with the baseline adaptation night adverse effect were actively monitored over the duration of the study interventions (distributed over approx. two weeks for each subject); monitoring specifically included all 5 nights spent in the sleep lab (adaptation night #1, first intervention nights 2&3, washout period, and second intervention nights 4&5)
Each study participant was further informed that adverse effects, should they occur outside the active monitoring period and/or after the study concluded, can be reported directly to either the sleep-lab manager, to the attending physician (T. Uhde), or to the clinical psychologist (A. Wilkerson).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Study Population | All participants completed an adaptation night (night #1) in the sleep lab including baseline assessment. Participants were treatment randomized to receive, after the adaptation night in the sleep lab, either two consecutive nights (night #2,#3) of "Active Low Field Magnetic Stimulation" followed by two consecutive nights (night #4,#5) of "Sham Low Field Magnetic Stimulation", or vice versa. A washout period was permitted between nights #3 and #4 when the intervention changed. Interventions: Active Low Field Magnetic Stimulation 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 (20 minutes before sleep) Sham Low Field Magnetic Stimulation 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 (20 minutes before sleep) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas W. Uhde, M.D. | Medical University of South Carolina | 843-792-0028 | uhde@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2016 | Dec 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| LFMS - Sham | Device | 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) |
|
| 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 |
| Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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 |
| MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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 |
| Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. | 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 |
| Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | inch |
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| Weight | Mean | Standard Deviation | lbm (pound mass) |
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| PSQI (Pittsburgh Sleep Quality Inventory) | Pittsburgh Sleep Quality Inventory (PSQI) is a well established 10-question questionnaire (24 items incl. sub-questions 5a-j and 10a-e) that assesses subjective sleep quality, -latency, -duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction. Individual items' responses are in the range of 0-3; a total PSQI score is derived by first deriving 7 equally weighted components from all 24 responses; each component is in the range of 0-3, resulting in a total score (sum of all components) of 0-21; a total PSQI score of >=5 is associated with poor sleep. | Mean | Standard Deviation | units on a scale |
|
| OG000 | Active Low Field Magnetic Stimulation | 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) |
| OG001 | Sham Low Field Magnetic Stimulation | 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) |
|
|
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| Primary | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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) | 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. | Posted | Mean | Standard Deviation | minutes | 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 |
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| Primary | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG). | 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. | Posted | Mean | Standard Deviation | minutes | 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 |
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| Primary | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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. | Posted | Mean | Standard Deviation | unitless ratio (0 to 1) | 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 |
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|
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| Primary | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale (0-100mm) | 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 |
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| Primary | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale (0-6) | 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 |
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| Secondary | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count. | 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. | Posted | Mean | Standard Deviation | awakenings | 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 |
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| Secondary | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. | 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. | Posted | Mean | Standard Deviation | units on a scale (0-100mm) | 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 |
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| Secondary | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale (0-100mm) | 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 |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D001523 |
| Mental Disorders |
| Change from Baseline WASO |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.08 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.221 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline TST |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.586 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.298 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline SE |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.210 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.190 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline EOS |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.196 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.092 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline SQS |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.004 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.042 | Equivalence | Significance level alpha=0.05; CI=95% |
| Sham or Active LFMS (two-night average) |
|
|
| Change from Baseline #awake |
|
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.379 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.284 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline fatigue |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.156 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.117 | Equivalence | Significance level alpha=0.05; CI=95% |
| Change from Baseline concentration |
|
This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero |
| t-test, 2 sided |
| 0.249 |
| Equivalence |
Significance level alpha=0.05; CI=95% |
| This is a crossover study; we use a paired t-test to test the hypothesis: H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ Note this paired t-test is equivalent to a one-sample t-test: H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero | t-test, 2 sided | 0.114 | Equivalence | Significance level alpha=0.05; CI=95% |