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The purpose of this study is to determine whether a small electrical current to the vestibular nerve (balance organ) will decrease the time it take for participants to fall asleep.
This 2 arm study will look at the proposed treatment (electrical stimulation of the vestibular nerve) versus a sham or placebo device. The effect of the device will be evaluated in a study that uses normal sleepers and advances them(puts them to bed 5-hours earlier than normal) to see if they fall asleep faster in one group or the other. Stimulation in the treated or sham group is only for the first hour after lights off.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- "VirtuSom" - Stim | Active Comparator | Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve). |
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| Group 2- "VirtuSom"- Sham | Placebo Comparator | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric stimulation of the Vestibular Nerve - "VirtuSom" | Device | This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Persistent Sleep (LPS) | Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up. | Treatment Night |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sleep Onset Latency (SOL) | Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes. | Treatment night |
| Total Sleep Time (TST) in the First 2 Hours After Lights Out |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Krystal | Duke University Medical Center, Duke Clinic Sleep Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Trials | Atlanta | Georgia | 30342 | United States | ||
| Sleep Disorders Center of Georgia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1- "VirtuSom" - Stim | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve). Electric stimulation of the Vestibular Nerve - "VirtuSom": This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM | Device | This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only. |
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Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out. |
| Treatment night |
| Total Sleep Time (TST) in the First Hour After Lights Out | Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out. | Treatment night |
| Scored Sleep Onset Latency (SOL on PSG) | Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG. | Treatment Night |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Clinilabs | New York | New York | 10019 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Tri-State Sleep Disorders Center | Cincinnati | Ohio | 45246 | United States |
| FG001 | Group 2- "VirtuSom"- Sham | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve). Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- "VirtuSom" - Stim | Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve). Electric stimulation of the Vestibular Nerve - "VirtuSom": This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. |
| BG001 | Group 2- "VirtuSom"- Sham | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve). Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Respiration | Mean | Standard Deviation | breaths per minute |
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| Pulse | Mean | Standard Deviation | beats per minute |
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| Sleep Onset Latency on Multiple Sleep Latency Test | Mean | Standard Deviation | minutes |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Latency to Persistent Sleep (LPS) | Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up. | Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group. | Posted | Mean | Standard Deviation | minutes | Treatment Night |
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| Secondary | Subjective Sleep Onset Latency (SOL) | Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes. | Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded. Not all participants answered this question the following morning, participants analyzed is less | Posted | Mean | Standard Deviation | minutes | Treatment night |
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| Secondary | Total Sleep Time (TST) in the First 2 Hours After Lights Out | Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out. | It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded. | Posted | Mean | Standard Deviation | minutes | Treatment night |
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| Secondary | Total Sleep Time (TST) in the First Hour After Lights Out | Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out. | It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded. | Posted | Mean | Standard Deviation | minutes | Treatment night |
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| Secondary | Scored Sleep Onset Latency (SOL on PSG) | Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG. | It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded. | Posted | Mean | Standard Deviation | minutes | Treatment Night |
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1 year
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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 | Group 1- "VirtuSom" - Stim | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve). Electric stimulation of the Vestibular Nerve - "VirtuSom": This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. | 0 | 176 | 9 | 176 | ||
| EG001 | Group 2- "VirtuSom"- Sham | Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve). Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only. | 0 | 173 | 11 | 173 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R.P. Chiacchierini & Associates | R.P. Chiacchierini & Associates | (240) 683-3738 | rpc@rpcaconsulting.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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