Trial Outcomes & Findings for Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness (NCT NCT00594022)
NCT ID: NCT00594022
Last Updated: 2019-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
349 participants
Primary outcome timeframe
Treatment Night
Results posted on
2019-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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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|---|---|---|
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Overall Study
STARTED
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176
|
173
|
|
Overall Study
COMPLETED
|
176
|
173
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
Baseline characteristics by cohort
| Measure |
Group 1- "VirtuSom" - Stim
n=176 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=173 Participants
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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Total
n=349 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
31.53 years
STANDARD_DEVIATION 7.56 • n=99 Participants
|
31.91 years
STANDARD_DEVIATION 7.74 • n=107 Participants
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31.76 years
STANDARD_DEVIATION 7.63 • n=206 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
237 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Region of Enrollment
United States
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176 participants
n=99 Participants
|
173 participants
n=107 Participants
|
349 participants
n=206 Participants
|
|
Body Mass Index
|
25.42 kg/m^2
STANDARD_DEVIATION 5.04 • n=99 Participants
|
26.00 kg/m^2
STANDARD_DEVIATION 5.42 • n=107 Participants
|
25.71 kg/m^2
STANDARD_DEVIATION 5.23 • n=206 Participants
|
|
Diastolic Blood Pressure
|
71.62 mmHg
STANDARD_DEVIATION 8.86 • n=99 Participants
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72.84 mmHg
STANDARD_DEVIATION 9.00 • n=107 Participants
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72.23 mmHg
STANDARD_DEVIATION 8.94 • n=206 Participants
|
|
Systolic Blood Pressure
|
113.57 mmHg
STANDARD_DEVIATION 12.39 • n=99 Participants
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115.64 mmHg
STANDARD_DEVIATION 11.91 • n=107 Participants
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114.60 mmHg
STANDARD_DEVIATION 12.18 • n=206 Participants
|
|
Respiration
|
16.49 breaths per minute
STANDARD_DEVIATION 2.19 • n=99 Participants
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16.82 breaths per minute
STANDARD_DEVIATION 1.88 • n=107 Participants
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16.65 breaths per minute
STANDARD_DEVIATION 2.05 • n=206 Participants
|
|
Pulse
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70.14 beats per minute
STANDARD_DEVIATION 9.99 • n=99 Participants
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69.43 beats per minute
STANDARD_DEVIATION 9.60 • n=107 Participants
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69.79 beats per minute
STANDARD_DEVIATION 9.79 • n=206 Participants
|
|
Sleep Onset Latency on Multiple Sleep Latency Test
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17.79 minutes
STANDARD_DEVIATION 1.90 • n=99 Participants
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17.93 minutes
STANDARD_DEVIATION 1.81 • n=107 Participants
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17.86 minutes
STANDARD_DEVIATION 1.86 • n=206 Participants
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PRIMARY outcome
Timeframe: Treatment NightPopulation: Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.
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.
Outcome measures
| Measure |
Group 1- "VirtuSom" - Stim
n=132 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=150 Participants
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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|---|---|---|
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Latency to Persistent Sleep (LPS)
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48.14 minutes
Standard Deviation 70.41
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58.84 minutes
Standard Deviation 87.03
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SECONDARY outcome
Timeframe: Treatment nightPopulation: 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
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.
Outcome measures
| Measure |
Group 1- "VirtuSom" - Stim
n=102 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=118 Participants
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.
|
|---|---|---|
|
Subjective Sleep Onset Latency (SOL)
|
79.16 minutes
Standard Deviation 97.78
|
87.91 minutes
Standard Deviation 101.16
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SECONDARY outcome
Timeframe: Treatment nightPopulation: 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.
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.
Outcome measures
| Measure |
Group 1- "VirtuSom" - Stim
n=113 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=129 Participants
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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|---|---|---|
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Total Sleep Time (TST) in the First 2 Hours After Lights Out
|
66.65 minutes
Standard Deviation 32.81
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64.17 minutes
Standard Deviation 36.75
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SECONDARY outcome
Timeframe: Treatment nightPopulation: 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.
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.
Outcome measures
| Measure |
Group 1- "VirtuSom" - Stim
n=113 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=129 Participants
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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|---|---|---|
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Total Sleep Time (TST) in the First Hour After Lights Out
|
33.84 minutes
Standard Deviation 16.01
|
30.51 minutes
Standard Deviation 18.15
|
SECONDARY outcome
Timeframe: Treatment NightPopulation: 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.
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.
Outcome measures
| Measure |
Group 1- "VirtuSom" - Stim
n=113 Participants
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.
|
Group 2- "VirtuSom"- Sham
n=129 Participants
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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|---|---|---|
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Scored Sleep Onset Latency (SOL on PSG)
|
27.50 minutes
Standard Deviation 49.79
|
31.28 minutes
Standard Deviation 50.03
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Adverse Events
Group 1- "VirtuSom" - Stim
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2- "VirtuSom"- Sham
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1- "VirtuSom" - Stim
n=176 participants at risk
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.
|
Group 2- "VirtuSom"- Sham
n=173 participants at risk
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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|---|---|---|
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Nervous system disorders
Headache
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5.1%
9/176 • Number of events 10 • 1 year
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6.4%
11/173 • Number of events 14 • 1 year
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Additional Information
R.P. Chiacchierini & Associates
R.P. Chiacchierini & Associates
Phone: (240) 683-3738
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place