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NCT03590795 · ClinicalTrials.gov registry record
VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
A clinical trial of Sleep, sponsored by Philips Respironics.
- Completed
- Registry status
- 204
- Enrollment target
- 6
- Study locations
NCT03590795: Completed study of Sleep, sponsored by Philips Respironics.
NCT03590795 is a study of Sleep that has completed, run by Philips Respironics. The registered enrollment target is 204 participants, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03590795, a study of Sleep, has completed, sponsored by Philips Respironics.
- COMPLETED
- Registry status
- 204 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Sleep survey
Study Locations (6)
Alabama
- Sleep Disorders Center of Alabama - Birmingham
Florida
- Florida Lung & Sleep Associates - Lehigh Acres
Georgia
- NeuroTrials Research Inc. - Atlanta
Maryland
- Center for Sleep and Wake Disorders - Chevy Chase
Missouri
- Clayton Sleep Institute - St Louis
Texas
- Sleep Therapy and Research Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2018-09-07 |
What the finished NCT03590795 record still lists
NCT03590795 is an observational study that tracks outcomes without assigning an intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Sleep appearing as the primary indexed condition, and to 1 intervention - of which Sleep survey is the first listed.
NCT03590795 lists 6 locations in 6 states (Alabama, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT03590795 about?
NCT03590795 is a clinical study titled "VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)". 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 speci...
What is the current status of trial NCT03590795?
This trial is currently completed. The enrollment target is 204 participants. The study started on 2018-06-19. Estimated completion is 2018-09-07.
What conditions does trial NCT03590795 study?
This clinical trial studies the following conditions: Sleep.
What interventions are being tested in trial NCT03590795?
The interventions under investigation include: Sleep survey (OTHER).
Who is sponsoring clinical trial NCT03590795?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03590795 being conducted?
This trial has 6 study locations across Alabama, Florida, Georgia, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03590795's enrollment target sits among peer trials
204 26th of 151 higher than 126 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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