Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness (VSOM)

Philips

Status: Completed

Conditions: Sleeplessness; Insomnia; Transient Insomnia

Treatments: Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM; Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"

Study type: Interventional

Funder types: Industry

Identifiers

NCT00594022

MR-0707-VSOM-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 349 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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349 participants in 2 patient groups, including a placebo group

Group 1- "VirtuSom" - Stim

Active Comparator group

Description:

Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) \>=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).

Treatment:

Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"

Group 2- "VirtuSom"- Sham

Placebo Comparator group

Description:

Normal sleepers (7.5 - 9.0 hours), MSLT \>=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).

Treatment:

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