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

Completed

Conditions studied: Sleep

In brief

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.

Key facts

Study ID

NCT03590795

Run by

Philips Respironics

People needed

204

Starts

2018-06-19

Expected to finish

2018-09-07

Last updated by the study team

2018-09-21

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age: 20-75 years old.
• Able to provide written informed consent
• Able to read, write and speak English

You may not qualify if…

• 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).

Where it is running

• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
• Florida Lung & Sleep Associates — Lehigh Acres, Florida, United States
• NeuroTrials Research Inc. — Atlanta, Georgia, United States
• Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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