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Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

NCT00594022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2019-01-07

Study results available
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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.

Conditions

  • Insomnia
  • Sleeplessness
  • Transient Insomnia

Interventions

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.

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.

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Andrew Krystal · Duke University Medical Center, Duke Clinic Sleep Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594022 on ClinicalTrials.gov