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

Philips Respironics6 sites in 1 country349 target enrollmentOctober 2007

ConditionsInsomnia Sleeplessness Transient Insomnia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Insomnia
Sponsor: Philips Respironics
Enrollment: 349
Locations: 6
Primary Endpoint: Latency to Persistent Sleep (LPS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

July 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Philips Respironics

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Latency to Persistent Sleep (LPS)

Time Frame: Treatment Night

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.