VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:20 - 75
Updated:9/23/2018
Start Date:June 19, 2018
End Date:September 7, 2018

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Sleep is an important contributing factor to people's health. However, over one third of the
general population has sleep complaints, causing both health related problems, and economic
impact. Many do not think their problem sleep is serious enough to consult a physician
(primary care or sleep specialist). For a selection of this population, self-tracking devices
can be a solution, but these trackers are often activity based and therefore lacking in their
capacity to give insight into underlying causes of poor quality sleep and daytime fatigue.

A new options for these confused sleeper is an online questionnaire, developed by Philips and
Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled
sleeper awake at 3 am, they search "Why can't I sleep?" and find the survey. From there the
user takes the sleep survey, which has the ability to assess their most likely sleep problem
or problems from a list of seven sleep problem categories based upon their responses. At the
end of the survey, participants will get information about which problem category they will
fall into, and the level of certainty around that.

The purpose of the study is to determine the accuracy of the questionnaire in identifying the
correct sleep problem when compared with the assessment of a sleep physician in a clinical
sleep center. We hope to enroll 200 participants which was based upon an Initial power
analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a
total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%).
Participants will complete the survey, be blinded to the results, and then have a
consultation with a sleep physician who will make an independent assessment.


Inclusion Criteria:

- Age: 20-75 years old.

- Able to provide written informed consent

- Able to read, write and speak English

Exclusion Criteria:

- Has seen a sleep physician previously for formal clinical evaluation of a potential
sleep problem.

- Is being treated for any sleep disorder.

- Has a major psychiatric disorder that is unstable at the time of evaluation.

- Has a major medical condition likely to contribute to and thus to confound any sleep
problem (congestive heart failure, severe Chronic Obstructive Pulmonary Disease
(COPD), a pain syndrome, etc).
We found this trial at
6
sites
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
Principal Investigator: Russell Rosenberg, MD
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790 Montclair Road
Birmingham, Alabama 35213
205-599-1020
Principal Investigator: Robert Doeckel
Phone: (205)599-1020
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Birmingham, AL
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Chevy Chase, Maryland 20815
Principal Investigator: Helene Emsellem, MD
Phone: 301-654-5665
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Chevy Chase, MD
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Lehigh Acres, Florida 33971
Principal Investigator: Alaa El-Gendry
Phone: 239-369-3333
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Lehigh Acres, FL
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Saint Louis, Missouri 63143
Principal Investigator: Joseph Ojile, MD
Phone: 314-645-6005
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Saint Louis, MO
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San Antonio, Texas 78229
Principal Investigator: James Andry, MD
Phone: 210-614-6000
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San Antonio, TX
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