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

NCT ID: NCT03590795

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2018-09-07

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.

Conditions

Sleep

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Problem Sleepers

Those individuals that have self identified as having a unspecified sleep problem will take the sleep survey.

Sleep survey

Intervention Type: OTHER

The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry \[including Philips\]).

Interventions

Sleep survey

The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry \[including Philips\]).

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cooperative Research Center (CRC) for Alertness, Safety and Productivity

UNKNOWN

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

SRC-AI-SC-2018-10138

Identifier Type: -

Identifier Source: org_study_id