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Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time

NCT00594022•Philips Respironics

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.

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.

Eligibility

Age

21 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.
+6 more criteria

Locations (6)

Neuro Trials

Atlanta, Georgia, United States

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

Clinilabs

New York, New York, United States

University of Rochester

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Tri-State Sleep Disorders Center

Cincinnati, Ohio, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

June 1, 2008

Completion Date

July 1, 2008

Last Updated

January 7, 2019

Enrollment

349

ACTUAL participants

Conditions

InsomniaSleeplessnessTransient Insomnia

Interventions

Electric stimulation of the Vestibular Nerve - "VirtuSom"

DEVICE

Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM

DEVICE

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

NCT06032377

Insomnia

View study

RECRUITINGNA

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

NCT06807086

Insomnia Chronic

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RECRUITINGNA

Innovating CBT-I for Cancer Survivors: An Optimization Trial

NCT06181643

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Inclusion Criteria

Exclusion Criteria

Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

Innovating CBT-I for Cancer Survivors: An Optimization Trial

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Project Women's Insomnia Sleep Health Equity Study (WISHES)