InsomniaVSOMNCT00594022
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
A study testing Electric stimulation of the Vestibular Nerve - "VirtuSom" in people with Insomnia and Sleeplessness, run by Philips Respironics at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Sleeplessness, Transient Insomnia
- What is being tested?
- Electric stimulation of the Vestibular Nerve - "VirtuSom"
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Neuro Trials
Atlanta, Georgia, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246
Duke University Medical Center
Durham, North Carolina, 27710
Clinilabs
New York, New York, 10019
University of Rochester
Rochester, New York, 14642
About this study
Official title: The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time
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.
Read the 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.
- Conditions
- Insomnia, Sleeplessness, Transient Insomnia
- Being tested
- Electric stimulation of the Vestibular Nerve - "VirtuSom", Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM
- Keywords
- Electric Stimulation, Latency to Persistent Sleep (LPS), Transient Insomnia, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Electric stim of the Vestibular Nerve - "VirtuSom" - SHAMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Electric stimulation of the Vestibular Nerve - "VirtuSom" |
| 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). Receives: Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment Night
Secondary outcomes (4)
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.
Measured: Treatment night
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.
Measured: 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.
Measured: 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.
Measured: Treatment Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, Principal investigator, Duke University Medical Center, Duke Clinic Sleep Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594022
- Sponsor's protocol ID
- MR-0707-VSOM-MS
- Acronym
- VSOM
- Status last verified
- Dec 2018
- First submitted
- 26 Dec 2007
- Last updated
- 7 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time
- ClinicalTrials.gov ID
- NCT00594022
- Acronym / sponsor ID
- VSOM / MR-0707-VSOM-MS
- Conditions
- Insomnia, Sleeplessness, Transient Insomnia
- Keywords
- Electric Stimulation, Latency to Persistent Sleep (LPS), Transient Insomnia, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- "VirtuSom" - Stim | Active comparator | Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"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). |
| Group 2- "VirtuSom"- Sham | Placebo comparator | Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAMNormal 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). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group 1- "VirtuSom" - Stim |
| Electric stim of the Vestibular Nerve - "VirtuSom" - SHAMThis 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. | Device | Group 2- "VirtuSom"- Sham |
Primary outcome
Latency to Persistent Sleep (LPS)
Time frame: 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.
4 secondary outcomes
Subjective Sleep Onset Latency (SOL)
Time frame: Treatment night
Total Sleep Time (TST) in the First 2 Hours After Lights Out
Time frame: Treatment night
Total Sleep Time (TST) in the First Hour After Lights Out
Time frame: Treatment night
Scored Sleep Onset Latency (SOL on PSG)
Time frame: Treatment Night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Krystal principal investigator
Duke University Medical Center, Duke Clinic Sleep Lab
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric stimulation of the Vestibular Nerve - "VirtuSom" in people with Insomnia and Sleeplessness, run by Philips Respironics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to Persistent Sleep (LPS) (time frame: Treatment Night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.