VSOM: Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00594022
• Collaborator: (none)
• Enrollment: 349
• Locations: 6
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 58.2
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Sleeplessness; Transient Insomnia	Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"; Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 349 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Device: 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.
Placebo Comparator: 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).	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Latency to Persistent Sleep (LPS) [Treatment Night]

   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.

Secondary Outcome Measures

1. Subjective Sleep Onset Latency (SOL) [Treatment night]

   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.

2. Total Sleep Time (TST) in the First 2 Hours After Lights Out [Treatment night]

   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.

3. Total Sleep Time (TST) in the First Hour After Lights Out [Treatment night]

   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.

4. Scored Sleep Onset Latency (SOL on PSG) [Treatment Night]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Males and females, ages 21- 50 attempts will be made to enroll equal distributions of males and females

• Able and willing to provide written informed consent

• Self reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than 1 hour at least 5 nights per week

• Self reported 7.5-9 hrs. habitual sleep time

• Able to commit to 9 hrs of sleep opportunity throughout the study, but especially for the 3 nights prior to their PSG

• Pass Berlin questionnaire, i.e. low likelihood of sleep disordered breathing

• No history or evidence of RLS(restless leg syndrome) /PLMS (periodic limb movement syndrome) /Narcolepsy, no non-respiratory related sleep disorders.

Exclusion Criteria:

• Regular use of a pack or more per day of tobacco products

• Typically consumes more than 2 (12 oz) caffeinated beverages per day

• Self reported history of motion sickness

• Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study

• Clinically significant medical or psychiatric condition as determined by the investigator

• Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder

• History of current or recent (e.g. within past 5 years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV)

• Currently works night shift or rotating shift

• Travel or planned travel across more than 1 time zone within one week prior to randomization

• Use of any medication that, in the opinion of the investigator, may alter sleep or wakefulness. (See Appendix E: Guideline For Medications Commonly Associated With Alterations Of Sleep / Wake Functioning). Subjects will undergo urine drug testing.

• Consumption of more than 14 alcoholic drinks per week, or the recent consumption of more than 4 alcoholic drinks in one night. Subjects will be tested for alcohol, using a saliva test kit.

• Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women's of child bearing age).

• Presence of a pacemaker

• Presence of epilepsy or other uncontrolled medical conditions.

• Prior participation in a VirtuSom protocol

• History of vestibular disorders, (such as vertigo)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuro Trials	Atlanta	Georgia	United States	30342
2	Sleep Disorders Center of Georgia	Atlanta	Georgia	United States	30342
3	Clinilabs	New York	New York	United States	10019
4	University of Rochester	Rochester	New York	United States	14642
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	Tri-State Sleep Disorders Center	Cincinnati	Ohio	United States	45246

Sponsors and Collaborators

• Philips Respironics

Investigators

• Principal Investigator: Andrew Krystal, Duke University Medical Center, Duke Clinic Sleep Lab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT00594022
• Other Study ID Numbers: MR-0707-VSOM-MS
• First Posted: Jan 15, 2008
• Last Update Posted: Jan 7, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Philips Respironics: Electric Stimulation; Latency to Persistent Sleep (LPS); Transient Insomnia; Insomnia
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	176	173
COMPLETED	176	173
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	176	173	349
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.53 (7.56)	31.91 (7.74)	31.76 (7.63)
Sex: Female, Male (Count of Participants)
Female	119 67.6%	118 68.2%	237 67.9%
Male	57 32.4%	55 31.8%	112 32.1%
Region of Enrollment (participants) [Number]
United States	176 100%	173 100%	349 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.42 (5.04)	26.00 (5.42)	25.71 (5.23)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	71.62 (8.86)	72.84 (9.00)	72.23 (8.94)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	113.57 (12.39)	115.64 (11.91)	114.60 (12.18)
Respiration (breaths per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [breaths per minute]	16.49 (2.19)	16.82 (1.88)	16.65 (2.05)
Pulse (beats per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats per minute]	70.14 (9.99)	69.43 (9.60)	69.79 (9.79)
Sleep Onset Latency on Multiple Sleep Latency Test (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	17.79 (1.90)	17.93 (1.81)	17.86 (1.86)

Outcome Measures

1. Primary Outcome

Title	Latency to Persistent Sleep (LPS)
Description	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.
Time Frame	Treatment Night

Outcome Measure Data

Analysis Population Description

Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Measure Participants	132	150
Mean (Standard Deviation) [minutes]	48.14 (70.41)	58.84 (87.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1- "VirtuSom" - Stim, Group 2- "VirtuSom"- Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.1275
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	Subjective Sleep Onset Latency (SOL)
Description	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.
Time Frame	Treatment night

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Measure Participants	102	118
Mean (Standard Deviation) [minutes]	79.16 (97.78)	87.91 (101.16)

3. Secondary Outcome

Title	Total Sleep Time (TST) in the First 2 Hours After Lights Out
Description	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.
Time Frame	Treatment night

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Measure Participants	113	129
Mean (Standard Deviation) [minutes]	66.65 (32.81)	64.17 (36.75)

4. Secondary Outcome

Title	Total Sleep Time (TST) in the First Hour After Lights Out
Description	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.
Time Frame	Treatment night

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Measure Participants	113	129
Mean (Standard Deviation) [minutes]	33.84 (16.01)	30.51 (18.15)

5. Secondary Outcome

Title	Scored Sleep Onset Latency (SOL on PSG)
Description	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.
Time Frame	Treatment Night

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1- "VirtuSom" - Stim	Group 2- "VirtuSom"- Sham
Arm/Group Description	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.	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.
Measure Participants	113	129
Mean (Standard Deviation) [minutes]	27.50 (49.79)	31.28 (50.03)

Adverse Events

Time Frame	1 year
Arm/Group Title	Group 1- "VirtuSom" - Stim		Group 2- "VirtuSom"- Sham
Arm/Group Description	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.		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.
All Cause Mortality
	Group 1- "VirtuSom" - Stim		Group 2- "VirtuSom"- Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1- "VirtuSom" - Stim		Group 2- "VirtuSom"- Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/176 (0%)		0/173 (0%)
Other (Not Including Serious) Adverse Events
	Group 1- "VirtuSom" - Stim		Group 2- "VirtuSom"- Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/176 (5.1%)		11/173 (6.4%)
Nervous system disorders
Headache	9/176 (5.1%)	10	11/173 (6.4%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.