Clinical trial NCT00594022: Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
Official title: The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleeplessness
Transient Insomnia
Keywords: Electric Stimulation
Latency to Persistent Sleep (LPS)
Transient Insomnia
Insomnia
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 349
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Latency to Persistent Sleep (LPS)
timeFrame: Treatment Night
Secondary outcomes:
measure: Subjective Sleep Onset Latency (SOL)
timeFrame: Treatment night
measure: Total Sleep Time (TST) in the First 2 Hours After Lights Out
timeFrame: Treatment night
measure: Total Sleep Time (TST) in the First Hour After Lights Out
timeFrame: Treatment night
measure: Scored Sleep Onset Latency (SOL on PSG)
timeFrame: Treatment Night
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Neuro Trials
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: New York
country: United States
facility: Clinilabs
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center
state: Ohio
Study officials:
affiliation: Duke University Medical Center, Duke Clinic Sleep Lab
name: Andrew Krystal
role: PRINCIPAL_INVESTIGATOR
References: