VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
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|ClinicalTrials.gov Identifier: NCT03590795|
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : September 21, 2018
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.
|Condition or disease||Intervention/treatment|
|Sleep||Other: Sleep survey|
|Study Type :||Observational|
|Actual Enrollment :||204 participants|
|Official Title:||VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)|
|Actual Study Start Date :||June 19, 2018|
|Actual Primary Completion Date :||September 7, 2018|
|Actual Study Completion Date :||September 7, 2018|
Those individuals that have self identified as having a unspecified sleep problem will take the sleep survey.
Other: Sleep survey
The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]).
- The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification [ Time Frame: 1 day ]The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification. Percent agreement will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval (CI).
- Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications. [ Time Frame: 1 day ]Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications. This will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590795
|United States, Alabama|
|Sleep Disorders Center of Alabama|
|Birmingham, Alabama, United States, 35213|
|United States, Florida|
|Florida Lung & Sleep Associates|
|Lehigh Acres, Florida, United States, 33971|
|United States, Georgia|
|NeuroTrials Research Inc.|
|Atlanta, Georgia, United States, 30342|
|United States, Maryland|
|Center for Sleep and Wake Disorders|
|Chevy Chase, Maryland, United States, 20815|
|United States, Missouri|
|Clayton Sleep Institute|
|Saint Louis, Missouri, United States, 63143|
|United States, Texas|
|Sleep Therapy and Research Center|
|San Antonio, Texas, United States, 78229|