Clinical trial NCT03590795: VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
Official title: VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
Collaborators: name: Cooperative Research Center (CRC) for Alertness, Safety and Productivity
First posted: 2018-07-18
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification
timeFrame: 1 day
Secondary outcomes:
measure: Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications.
timeFrame: 1 day
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Lehigh Acres
country: United States
facility: Florida Lung & Sleep Associates
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Chevy Chase
country: United States
facility: Center for Sleep and Wake Disorders
state: Maryland
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
References: