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 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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Sleep survey

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • Florida
    • Lehigh Acres, Florida, United States, 33971
      • Florida Lung & Sleep Associates
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc.
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Center For Sleep and Wake Disorders
  • Missouri
    • Saint Louis, Missouri, United States, 63143
      • Clayton Sleep Institute
  • Texas
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification	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).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications.	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.	1 day

Collaborators and Investigators

• Sponsor: Philips Respironics
• Collaborators: Cooperative Research Center (CRC) for Alertness, Safety and Productivity

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): September 7, 2018
• Study Completion (Actual): September 7, 2018

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SRC-AI-SC-2018-10138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data sets will be shared with academic institutions for development purposes
• IPD Sharing Time Frame: After final study analysis data will be available for up to 5 years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No