N/A
N=349
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
Insomnia · Sleeplessness · Transient Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00594022 ↗Enrolled (actual)
349
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Latency to Persistent Sleep (LPS) — 48.14; 58.84 minutes — p=.1275
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electric stimulation of the Vestibular Nerve - "VirtuSom" (Device); Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Persistent Sleep (LPS) |
48.14; 58.84 | .1275 |
| SECONDARY Subjective Sleep Onset Latency (SOL) |
79.16; 87.91 | — |
| SECONDARY Total Sleep Time (TST) in the First 2 Hours After Lights Out |
66.65; 64.17 | — |
| SECONDARY Total Sleep Time (TST) in the First Hour After Lights Out |
33.84; 30.51 | — |
| SECONDARY Scored Sleep Onset Latency (SOL on PSG) |
27.50; 31.28 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00594022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.