Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness

Insomnia Clinical Trial

— VSOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594022
• Other study ID #: MR-0707-VSOM-MS
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: December 2018
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Sleeplessness
• Transient Insomnia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Neuro Trials	Atlanta	Georgia
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Tri-State Sleep Disorders Center	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Clinilabs	New York	New York
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to Persistent Sleep (LPS)	Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up.	Treatment Night
Secondary	Subjective Sleep Onset Latency (SOL)	Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes.	Treatment night
Secondary	Total Sleep Time (TST) in the First 2 Hours After Lights Out	Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out.	Treatment night
Secondary	Total Sleep Time (TST) in the First Hour After Lights Out	Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out.	Treatment night
Secondary	Scored Sleep Onset Latency (SOL on PSG)	Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG.	Treatment Night