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Completed

NCT Number: NCT03590795

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleep survey

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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