Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness (VSOM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT00594022
First received: December 26, 2007
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Insomnia
Sleeplessness
Transient Insomnia
Device: Electric stimulation of the Vestibular Nerve - "VirtuSom"
Device: Electric stim of the Vestibular Nerve - "VirtuSom" - SHAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vestibular Stimulation on Transient Insomnia Induced by a Five-hour Phase Advance of Sleep Time

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Latency to Persistent Sleep (LPS) [ Time Frame: Treatment Night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Sleep Onset Latency (SOL) [ Time Frame: Treatment night ] [ Designated as safety issue: No ]
  • Total Sleep Time (TST) in the First 2 Hours After Lights Out [ Time Frame: Treatment night ] [ Designated as safety issue: No ]
  • Total Sleep Time (TST) in the First Hour After Lights Out [ Time Frame: Treatment night ] [ Designated as safety issue: No ]
  • Scored Sleep Onset Latency (SOL on PSG) [ Time Frame: Treatment Night ] [ Designated as safety issue: No ]

Enrollment: 349
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1- "VirtuSom" - Stim
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).
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.
Placebo Comparator: Group 2- "VirtuSom"- Sham
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).
Device: 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.

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

Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594022

Locations
United States, Georgia
Neuro Trials
Atlanta, Georgia, United States, 30342
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, New York
Clinilabs
New York, New York, United States, 10019
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45246
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Andrew Krystal Duke University Medical Center, Duke Clinic Sleep Lab
  More Information

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT00594022     History of Changes
Other Study ID Numbers: MR-0707-VSOM-MS 
Study First Received: December 26, 2007
Results First Received: July 13, 2016
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Philips Respironics:
Electric Stimulation
Latency to Persistent Sleep (LPS)
Transient Insomnia
Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2016