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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
Sponsor:
Collaborator:
Cooperative Research Center (CRC) for Alertness, Safety and Productivity
Information provided by (Responsible Party):
Philips Respironics

Brief 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.


Condition or disease Intervention/treatment
Sleep Other: Sleep survey

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Other
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Problem Sleepers
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]).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will be those who are new patients to the sleep lab or those recruited from a central recruiter that may or may not have sleep issues.
Criteria

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).

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Philips Respironics
Cooperative Research Center (CRC) for Alertness, Safety and Productivity

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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT03590795     History of Changes
Other Study ID Numbers: SRC-AI-SC-2018-10138
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data sets will be shared with academic institutions for development purposes
Time Frame: After final study analysis data will be available for up to 5 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No