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N/A N=349 Randomized Triple-blind Treatment

Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Insomnia · Sleeplessness · Transient Insomnia

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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