Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
VSOM
The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time
1 other identifier
interventional
349
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
August 23, 2016
CompletedJanuary 7, 2019
December 1, 2018
8 months
December 26, 2007
July 13, 2016
December 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Subjective Sleep Onset Latency (SOL)
Treatment night
Total Sleep Time (TST) in the First 2 Hours After Lights Out
Treatment night
Total Sleep Time (TST) in the First Hour After Lights Out
Treatment night
Scored Sleep Onset Latency (SOL on PSG)
Treatment Night
Study Arms (2)
Group 1- "VirtuSom" - Stim
ACTIVE COMPARATORNormal 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 COMPARATORNormal 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Neuro Trials
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of Georgia
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- R.P. Chiacchierini & Associates
- Organization
- R.P. Chiacchierini & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Krystal
Duke University Medical Center, Duke Clinic Sleep Lab
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 15, 2008
Study Start
October 1, 2007
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
January 7, 2019
Results First Posted
August 23, 2016
Record last verified: 2018-12