Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness (NCT00594022) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
United States349 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range21 Years – 50 Years
SexALL
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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 Psy…